The Recall Desk

Archive

August 2023 recalls

693 recalls were announced in August 2023.

What the numbers show

Critical
15
Severe
87
High
526
Moderate
65

Of the 693 recalls this month scored against our rubric, 2% are Critical, 13% are Severe.

501–600 of 693

  • HighFDA (Food)·F-1316-2023·2023-08-09

    Blanched Hazelnuts Recalled for Undeclared Allergens

    Houston Pecan Company is recalling blanched hazelnuts in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Consumers with allergies to these ingredients should not consume the product.

    Product
    Blanched Hazelnuts packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1346-2023·2023-08-09

    Cassano's Pizza King Dough Recalled for Undeclared Soy Flour

    Cassano's The Pizza King Proprietary Dough is being recalled due to undeclared soy flour. Consumers with soy allergies who consume this product may experience allergic reactions.

    Product
    Cassano's The Pizza King Proprietary Dough: packaged as 6in, 9in, 12in, 14in, and 16in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0978-2023·2023-08-09

    Heparin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 11,824 bags of heparin IV solution nationwide. The recall is due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1326-2023·2023-08-09

    Papaya Sweetened Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company recalls Papaya Sweetened in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross contamination. Affected products were distributed in Texas and through internet sales.

    Product
    Papaya Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2318-2023·2023-08-09

    Medical Procedural Kits Recalled Due to Ultrasound Gel Sterility Risk

    Medline Industries is recalling 1,182 sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2314-2023·2023-08-09

    Medline procedural kits with potentially non-sterile ultrasound gel recalled

    Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1055-2023·2023-08-09

    Hydromorphone Injection Syringes Recalled for Sterility Validation Deficiency

    Central Admixture Pharmacy Services is recalling 2,389 hydromorphone injection syringes distributed nationwide due to lack of validation data for sterilization procedures, which prevents assurance of product sterility.

    Product
    HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2023·2023-08-09

    Medline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure

    Medline Industries recalls 19,907 procedural kits because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1013-2023·2023-08-09

    Oxytocin IV bags recalled nationwide for insufficient sterility assurance

    Central Admixture Pharmacy Services recalled 2,692 bags of oxytocin IV solution nationwide because the company lacks data needed to prove the sterilization process is effective.

    Product
    oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2276-2023·2023-08-09

    OEC 9800 Fluoroscopy Systems Image Intensifier May Detach and Fall

    The image intensifier on GE OEC 9800 fluoroscopy systems can detach and fall if the system experiences a large impact force during movement. This could result in injuries including fractures, bruising, and contusion.

    Product
    OEC 9800 Systems with 9-inch Image Intensifier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1319-2023·2023-08-09

    Roasted Peanuts Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling roasted peanuts purchased before May 25, 2023, for undeclared allergen cross-contamination with tree nuts, peanuts, and wheat. The products were sold in Texas and through internet sales.

    Product
    Granulated Peanuts Roasted packaged in 5 pound bags; Virginia Peanuts Roasted NO SALT packaged in 5 pound bags; Spanish Peanuts Roasted & Salted packaged in 5 pound bags;
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1339-2023·2023-08-09

    Black Mission Figs Recalled for Undeclared Tree Nuts, Peanuts, Wheat

    Houston Pecan Company is recalling Black Mission Figs in 5-pound bags distributed in Texas and via internet due to undeclared tree nuts, peanuts, and wheat from allergen cross-contamination.

    Product
    Black Mission Figs Potassium Sorbate packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1048-2023·2023-08-09

    Vecuronium Injection Recalled Due to Lack of Sterility Validation

    Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.

    Product
    vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1076-2023·2023-08-09

    Rocuronium Syringes Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling rocuronium syringes due to lack of validation data for sanitization cycles, which cannot assure sterility. The recall affects 10,065 syringes distributed nationwide.

    Product
    rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2023·2023-08-09

    FDA Recalls Cardioplegia Solution for Lacking Sterility Validation Data

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used during heart surgery due to insufficient validation data for sterilization cycles. The 104-bag recall covers products distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2023·2023-08-09

    Philips Incisive CT Scanner Mounting Box Poses Injury Risk

    A metal mounting box in the Incisive CT Power scanner may detach and potentially injure operators or cause system failure. Philips is recalling 53 affected units distributed worldwide.

    Product
    Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0951-2023·2023-08-09

    FDA recalls dilTIAZem IV bags due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling 2,260 dilTIAZem IV bags nationwide because validation data for the decontamination process is lacking. Affected lots expire between July and August 2023.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0983-2023·2023-08-09

    FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 463 bags of oxytocin IV solution nationwide due to inadequate validation data for sterilization processes. The product may not meet FDA sterility standards required for injectable medications.

    Product
    oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1072-2023·2023-08-09

    Fentanyl-bupivacaine injectable drug recalled due to sterility concerns

    Central Admixture Pharmacy Services is recalling 896 bags of fentanyl-bupivacaine injectable solution nationwide due to lack of sterility assurance. The FDA Class II recall affects compounded pain medication lacking adequate sterilization validation.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1025-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services recalls Leesburg Cardioplegia Solution due to inadequate sterilization validation. The recall affects 36 bags distributed nationwide.

    Product
    CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2252-2023·2023-08-09

    Fusion Lithotripsy Extraction Baskets recalled for mechanical defects

    Wilson-Cook Medical's Fusion Lithotripsy Extraction Baskets are being recalled due to mechanical defects that can prevent the basket from advancing or retracting, or cause the drive wire to break or separate during use.

    Product
    Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1007-2023·2023-08-09

    Neonatal TPN Starter Bag Recalled Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling a neonatal IV nutrition bag due to lack of sterility assurance. The recall affects 156 bags of the product distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,NDC: 72196-0407-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1069-2023·2023-08-09

    Injectable Fentanyl-Bupivacaine Mixture Recalled for Sterility Validation Failure

    Central Admixture Pharmacy Services recalls 295 bags of injectable fentanyl-bupivacaine solution nationwide because the sterilization process lacked proper validation documentation.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1070-2023·2023-08-09

    Fentanyl and Bupivacaine Injectable Recalled for Sterility Concerns

    Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed nationwide.

    Product
    fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0957-2023·2023-08-09

    Epinephrine IV Bags Recalled Due to Unvalidated Sterility Process

    Central Admixture Pharmacy Services is recalling 333 units of epinephrine 2 mg in dextrose 5% IV bags because validation data for sterilization procedures is lacking, raising concerns about product sterility assurance.

    Product
    EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1315-2023·2023-08-09

    Walnuts Recalled for Undeclared Tree Nuts, Peanuts, and Wheat Allergens

    Houston Pecan Company is recalling 5-pound bags of walnuts that may contain undeclared tree nuts, peanuts, and wheat due to cross-contamination. Affected products were sold in Texas and through internet sales.

    Product
    Walnut Halves packaged in 5 pound bag; Walnuts Medium Pices packaged in 5 pound bags; Walnuts Halves & Large Pieces packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0980-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services recalled 52 neonatal TPN starter bags nationwide due to lack of validation data for sterilization processes, raising concerns about sterility assurance.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and HEPARIN, IV Bag, Total Volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0430-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0993-2023·2023-08-09

    Neonatal IV Nutrition Bags Recalled Due to Sterility Assurance Defect

    Central Admixture Pharmacy Services is recalling 188 neonatal TPN bags nationwide because sterility assurance cannot be guaranteed. Validation data for decontamination cycles is lacking.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0416-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1024-2023·2023-08-09

    Cardioplegia solution IV bags recalled for lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0961-2023·2023-08-09

    Phenylepherine IV bags recalled due to sterility assurance concerns

    Central Admixture Pharmacy Services is recalling over 8,300 phenylepherine IV bags nationwide because sterilization procedures were not adequately validated. Sterility cannot be assured for the affected units.

    Product
    PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0988-2023·2023-08-09

    Norepinephrine IV bags recalled for sterility validation deficiency

    Central Admixture Pharmacy Services recalled 80 bags of norepinephrine IV solution due to lack of sterility assurance and insufficient validation data for decontamination cycles. Product was distributed nationwide.

    Product
    norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2023·2023-08-09

    Medline Anesthesia Procedural Kits Recalled for Potential Sterility Failure

    Medline Industries recalls 1,130 anesthesia procedural kits over concerns that the sterile ultrasound gel component may not meet sterility specifications. The kits were distributed worldwide including the US from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANESTHESIA CVL KIT-LF, Model Number: DYNJ52283C; b. ANESTHESIA OH TOTE, Model Number: DYNJ61476;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2023·2023-08-09

    Medical procedural kits recalled due to sterility concerns with ultrasound gel

    Medline recalls 76,870 procedural kits because the ultrasound gel component may not meet sterility standards. Kits were distributed nationwide and internationally from April 2020 through April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2023·2023-08-09

    Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements

    Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1360-2023·2023-08-09

    belVita Breakfast Sandwich Recall: Undeclared Peanut Allergen

    Mondelez Global LLC recalls belVita Breakfast Sandwich (Dark Chocolate Creme variety) due to undeclared peanut allergen from cross contamination. The product was distributed to all 50 states.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0976-2023·2023-08-09

    FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.

    Product
    oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2023·2023-08-09

    Procedural Kits Containing Ultrasound Gel Recalled for Sterility Concerns

    Medline Industries is recalling 130 custom procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2023·2023-08-09

    Medline Procedural Kits Recalled for Potentially Non-Sterile Gel

    Medline Industries is recalling 1,218 procedural kits because the sterile ultrasound gel component may not meet sterility specifications, potentially posing an infection risk in invasive procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1000-2023·2023-08-09

    Neonatal TPN Bags Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 516 Neonatal TPN Starter Bags due to insufficient validation of decontamination processes. The recall affects bags distributed nationwide.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0954-2023·2023-08-09

    EPINEPHrine IV bags recalled nationwide due to lack of sterility assurance

    Central Admixture Pharmacy Services is recalling 9,121 epinephrine IV bags distributed nationwide due to lack of sterility assurance and insufficient validation data for decontamination cycles.

    Product
    EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2023·2023-08-09

    Medline Ultrasound Gel in Surgical Kits May Not Meet Sterility Standards

    Medline is recalling approximately 9,017 breast biopsy and ultrasound surgical kits due to potential sterility failures in the included ultrasound gel component. No illnesses have been reported.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREAST BIOPSY KIT, Model Number: DYNDA1224A, DYNDA1224B; b. BREAST BIOPSY TRAY, Model Number: SPEC0130C; c. BREAST IMAGING TRAY, Model Number: MNS11895…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1348-2023·2023-08-09

    DOUBLEDAY'S Premium Dough Recalled for Undeclared Soy Allergen

    DOUBLEDAY'S Premium Dough packages may contain undeclared soy flour, posing risk to consumers with soy allergies. The recall affects 24,575 cases distributed across nine states.

    Product
    DOUBLEDAY'S Premium Dough on Parchment: packaged as 8in, 9in, 10in, 12 in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-0966-2023·2023-08-09

    Vancomycin IV Bags Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 3,648 bags of vancomycin IV bags due to lack of assurance of sterility caused by insufficient validation data for decontamination cycles.

    Product
    vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6076-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2023·2023-08-09

    Medline Procedural Kit Ultrasound Gel Sterility Specification Failure

    Medline Industries is recalling procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed to healthcare facilities worldwide from 2020 to 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR MOTT DRAPE PACK, Model Number: DYNJ42065B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0948-2023·2023-08-09

    Vancomycin IV Bags Recalled Nationwide for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 3,980 IV vancomycin bags nationwide. The decontamination process was not properly validated, raising sterility concerns. No illnesses reported.

    Product
    vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2023·2023-08-09

    STATCLAVE G4 Medical Sterilizer Recalled for Incomplete Sterilization Risk

    FDA recalls 19 units of the STATCLAVE G4 steam sterilizer (Class II). The device may result in incomplete sterilization when used with incompatible materials.

    Product
    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0969-2023·2023-08-09

    Vancomycin IV bags recalled due to sterility assurance failure

    Central Admixture Pharmacy Services is recalling 6,782 bags of vancomycin IV bags distributed nationwide due to lack of validation data for decontamination cycles, which compromises sterility assurance.

    Product
    vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1059-2023·2023-08-09

    Fentanyl IV Bags Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.

    Product
    fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2023·2023-08-09

    Medline sterile procedural kits recalled for potential sterility specification failures

    Medline is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel due to potential sterility specification failures. The kits were distributed worldwide to hospitals and medical facilities.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V MINOR PACK, Model Number: DYNJ64862A; b. DBD-C SECTION ADM, Model Number: DYKL1816; c. FETAL SURGERY, Model Number: DYNJ908118A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2319-2023·2023-08-09

    Medline sterile procedural kits recalled for potentially non-sterile gel

    Medline is recalling 83,541 procedural kits because the included ultrasound gel component may not meet required sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1071-2023·2023-08-09

    Ketamine Injection Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 2,994 syringes of ketamine injection distributed nationwide due to lack of validated sterilization procedures that ensure product sterility.

    Product
    ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1031-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (100 mEq K) due to inadequate validation of decontamination processes. The recall affects 284 units distributed nationwide. Affected facilities should discontinue use and contact the manufacturer.

    Product
    CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag, total volume = 500 mL, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0107-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1347-2023·2023-08-09

    Prima Guida Sheeted Pizza Dough recalled for undeclared soy flour allergen

    Cassanos Inc is recalling Prima Guida Traditional Homestyle Sheeted Pizza Dough in multiple sizes due to undeclared soy flour. Consumers with soy allergies should not consume this product.

    Product
    Prima Guida Traditional Homestyle Sheeted Pizza Dough: packaged as 7in, 8in, 9in, 10in (regular), 10in (thin), 12in (thin), 12in (regular), 14 in (regular), 14in (thin), 16in (thin), 16in (regular), 18in
    Category
    Food
    Distribution
    9 states
  • HighFDA (Drugs)·D-1045-2023·2023-08-09

    Fentanyl Injection Syringes Recalled for Sterilization Validation Failure

    Central Admixture Pharmacy Services recalls 150 fentanyl injection syringes nationwide because sterilization procedures were not properly validated.

    Product
    fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2023·2023-08-09

    Sterile Procedural Kits Recalled Due to Potential Ultrasound Gel Sterility Failure

    Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel because the gel component may not meet sterility specifications. The kits are distributed worldwide for dialysis procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTION/DIALYSIS INSERTION TRAY, Model Number: CVI3845;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1054-2023·2023-08-09

    Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.

    Product
    fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0968-2023·2023-08-09

    Vancomycin IV Bags Recalled Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 2,914 bags of vancomycin IV medication nationwide due to lack of assurance of sterility caused by missing validation data for decontamination cycles.

    Product
    vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2023·2023-08-09

    Medline Surgical Procedural Kits Recalled Due to Sterility Concerns

    Medline Industries is recalling approximately 7,462 custom surgical procedural kits containing ultrasound gel because the gel component may not meet sterility specifications. The recall affects kits distributed worldwide since April 2020.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0964-2023·2023-08-09

    Phenylephrine IV bags recalled due to sterility validation gaps

    Central Admixture Pharmacy Services has recalled 472 phenylephrine IV bags distributed nationwide due to insufficient validation data for sterilization processes.

    Product
    phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1008-2023·2023-08-09

    Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1078-2023·2023-08-09

    Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure

    Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.

    Product
    PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2023·2023-08-09

    Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns

    Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile Procedural Kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Sterility Specification Failure

    Medline Industries recalls 15,945 Custom Sterile and Non-Sterile Procedural Kits due to potential failure of the Turkuaz ultrasound gel component to meet sterility specifications. The kits were distributed worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0950-2023·2023-08-09

    Vancomycin IV Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 4,824 bags of vancomycin IV medication nationwide due to inadequate validation of sterilization processes. The manufacturer cannot confirm proper sterility.

    Product
    vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel

    Medline Industries is recalling 7,040 custom sterile procedural kits containing ultrasound gel because the gel component may not meet sterility specifications, creating a potential infection risk.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1336-2023·2023-08-09

    Currants recalled for undeclared allergens: tree nuts, peanuts, wheat

    Houston Pecan Company, Inc. is recalling 5-pound bags of currants because they may contain undeclared tree nuts, peanuts, and wheat due to allergen cross contamination. The recall covers all bags purchased before May 25, 2023 in Texas and through internet sales.

    Product
    Currants packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1343-2023·2023-08-09

    Sweet & Salty Mix Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling Sweet & Salty Mix 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from cross-contamination. All bags purchased before May 25, 2023 are affected.

    Product
    Sweet & Salty Mix, Rst & Salted Peanuts, Rst & Salted Cashews, Raisins, Cranberries, Sunflower Seeds, Pumpkin Seeds, Sliced Almonds packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1046-2023·2023-08-09

    FDA Recalls Fentanyl Syringes for Sterility Assurance Failure

    Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product was distributed nationwide.

    Product
    fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2023·2023-08-09

    Medline Procedural Kits Recalled for Potential Sterility Failure

    Medline is recalling 13,881 sterile procedural kits worldwide due to potential sterility failure in the ultrasound gel component. The affected kits are used in various medical insertion procedures.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1363-2023·2023-08-09

    Mondelez Recalls belVita Breakfast Sandwiches for Undeclared Peanut Allergen

    Mondelez Global LLC is recalling belVita Breakfast Sandwiches (Dark Chocolate Creme variety) because they contain an undeclared peanut allergen due to cross contamination. Consumers with peanut allergies should not consume this product.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (192 - 2 lb 12 oz cartons per pallet)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1042-2023·2023-08-09

    FDA Recalls Fentanyl Injections Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 1,197 syringes of fentanyl injectable solution due to lack of validation for sterilization cycles. The product was distributed nationwide.

    Product
    fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1334-2023·2023-08-09

    Mango Slices Recalled for Undeclared Tree Nuts, Peanuts, and Wheat

    Houston Pecan Company is recalling mango slices due to potential undeclared allergens: tree nuts, peanuts, and wheat. Affected products are 5-pound bags distributed in Texas and sold online.

    Product
    Mango Slices, Mango, Cane Sugar, Citric Acid, Calcium Chloride, Sulfur Dioxide packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1018-2023·2023-08-09

    FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (High K) IV bags due to lack of sterility assurance from insufficient validation of decontamination processes.

    Product
    CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total volume = 542 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0212-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1036-2023·2023-08-09

    Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency

    Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.

    Product
    CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1362-2023·2023-08-09

    BelVita Breakfast Sandwich recalled for undeclared peanut allergen

    Mondelez is recalling belVita Breakfast Sandwich Dark Chocolate Creme and Cinnamon Brown Sugar varieties due to undeclared peanut allergen. The affected products were distributed to all 50 states.

    Product
    belVita Breakfast Sandwich, Dark Chocolate Creme variety (8 - 14.08 oz packages)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2299-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalls 104,755 procedural kits due to potential sterility defect in ultrasound gel component. No illnesses or injuries have been reported.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1014-2023·2023-08-09

    Neonatal TPN Starter Bags recalled due to sterility assurance failure

    Central Admixture Pharmacy Services is recalling 80 Neonatal TPN Starter Bags due to lack of sterile assurance. Decontamination cycle validation data was not available, creating a potential contamination risk.

    Product
    Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1056-2023·2023-08-09

    Succinylcholine Injectable Syringes Recalled for Sterility Validation Deficiency

    Central Admixture Pharmacy Services Inc recalls 12,239 succinylcholine injection syringes (200 mg/10 mL) distributed nationwide due to lack of validation data for sanitization cycles.

    Product
    succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1027-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.

    Product
    CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1338-2023·2023-08-09

    Dark Chocolate Pecans Recalled for Potential Undeclared Tree Nuts and Peanuts

    Houston Pecan Company is recalling dark chocolate pecans in 5-pound bags due to potential undeclared tree nuts, peanuts, and wheat from allergen cross-contamination. Consumers with allergies should not consume the product.

    Product
    Dark Chocolate Pecans packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1028-2023·2023-08-09

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 196 bags of cardioplegia solution nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1040-2023·2023-08-09

    Cardioplegia Solution IV Bags Recalled Due to Sterility Assurance

    Central Admixture Pharmacy Services is recalling 72 bags of Cardioplegia Solution due to insufficient validation data for product sterilization processes.

    Product
    CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2023·2023-08-09

    Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure

    Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0953-2023·2023-08-09

    IV Medication Recall: dilTIAZem Bags Lack Sterility Assurance

    Central Admixture Pharmacy Services is recalling 3,699 bags of dilTIAZem IV medication due to lack of assurance of sterility and missing validation data for decontamination cycles. The affected medication was distributed nationwide.

    Product
    dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0994-2023·2023-08-09

    Neonatal TPN Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalls 68 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility and missing validation data for decontamination cycles.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0415-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2254-2023·2023-08-09

    Zimmer Periarticular Locking Plate recalled due to thread form defect

    Zimmer Periarticular Locking Plates have a thread form defect that prevents surgical screws from properly mating with the plate. 75 units distributed across multiple U.S. states and internationally.

    Product
    Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-1043-2023·2023-08-09

    Fentanyl injection syringes recalled for unvalidated sterilization process

    Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.

    Product
    fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1044-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services Inc is recalling HYDROmorphone injectable syringes because sterilization cycles were not validated. The recall affects 2,717 units distributed nationwide.

    Product
    HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1335-2023·2023-08-09

    Sweetened Cranberries Recalled Due to Undeclared Allergen Cross Contamination

    Houston Pecan Company is recalling 5-pound bags of Sweetened Cranberries purchased before May 25, 2023. Product may contain undeclared tree nuts, peanuts, and wheat due to cross contamination. Distributed in Texas and via internet.

    Product
    Cranberries Sweetened packaged in 5 pound bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2326-2023·2023-08-09

    FDA Recalls Medline Procedural Kits Due to Potential Sterility Failure

    Medline Industries is recalling 22 procedural kits because the included ultrasound gel may not be sterile as labeled. The kits were distributed worldwide.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREMIUM CLOSUREPLUS PACK, Model Number: DYNJ54326A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2023·2023-08-09

    Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect

    Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1074-2023·2023-08-09

    Lidocaine Injectable Syringes Recalled for Sterilization Assurance Concerns

    CAPS Inc. is recalling 9,517 lidocaine 2% injectable syringes distributed nationwide due to lack of sterilization validation data. No illnesses have been reported.

    Product
    lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0962-2023·2023-08-09

    FDA Recalls Phenylephrine IV Bags Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling phenylephrine IV bags nationwide due to insufficient sterility assurance and lack of validation data for decontamination cycles used in manufacturing.

    Product
    phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7011-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1308-2023·2023-08-09

    Caesar Pasta Salad Recall: Undeclared Wheat, Milk, Soybean

    Eat Good LLC recalls Caesar Pasta Salad for undeclared wheat, milk, and soybean allergens. Affected products were distributed in Idaho, Montana, and Washington.

    Product
    Caesar Pasta Salad is a food service refrigerated product, packaged in 5lb flexible plastic packages, 2/5lb. packages are packed in cardboard cases. The salads are removed from the package and sold by the pound from deli display cases at the grocery stores. Caesar Pasta…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1060-2023·2023-08-09

    HYDROmorphone Injectable Syringes Recalled for Lack of Sterilization Validation

    Central Admixture Pharmacy Services is recalling 5,259 HYDROmorphone injectable syringes nationwide due to lack of validation data for sterilization, raising concerns about product sterility assurance.

    Product
    HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2269-2023·2023-08-09

    SPiN Xtend Instruments Recalled for Electromagnetic Sensor Tracking Malfunction

    Olympus Corporation is recalling 144 units of SPiN Xtend 2.0mm OD instruments (Model INS-5450) due to electromagnetic sensor tracking malfunction that impairs navigation during endobronchial procedures and may cause procedural delays.

    Product
    Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1047-2023·2023-08-09

    Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure sterility.

    Product
    fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1063-2023·2023-08-09

    Fentanyl Injectable Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.

    Product
    fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
    Category
    Drug
    Distribution
    Distributed nationwide

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