The Recall Desk

Archive

June 2022 recalls

857 recalls were announced in June 2022.

What the numbers show

Critical
29
Severe
235
High
450
Moderate
141
Low
2

Of the 857 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

401–500 of 857

  • HighFDA (Drugs)·D-1055-2022·2022-06-15

    Ibuprofen tablets recalled nationwide due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Ibuprofen 400 mg prescription tablets nationwide due to temperature abuse during manufacturing. The manufacturing deviation may affect drug stability and efficacy.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2022·2022-06-15

    Hilal Embolization Microcoils Recalled for Unintended Stainless-Steel Cannula

    Cook Incorporated is recalling Hilal Embolization Microcoils because their loading cartridges may contain an unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide and internationally.

    Product
    Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1061-2022·2022-06-15

    FDA Recalls Methylprednisolone Acetate Injection for Temperature Abuse During Distribution

    McKesson Medical-Surgical is recalling 885 vials of Methylprednisolone Acetate Injectable Suspension USP (40 mg/mL) due to cGMP deviations from temperature abuse. The product was distributed nationwide, but specific lot numbers could not be identified by the distributor.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1099-2022·2022-06-15

    Drug recall: Thrombin JMI injection kits due to manufacturing temperature deviation

    McKesson Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.

    Product
    Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1118-2022·2022-06-15

    Cefazolin Sodium Injectable Recalled Nationwide for Temperature Abuse

    McKesson Medical-Surgical recalled Cefazolin Sodium injectable (39 cases nationwide) due to temperature abuse during manufacturing that may compromise product sterility.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1229-2022·2022-06-15

    Elite Mini Mix Chocolate recalled for potential Salmonella contamination

    Elite Mini Mix Chocolate products are being recalled for potential Salmonella contamination. The FDA Class I recall affects all lots distributed nationwide.

    Product
    ELITE MINI MIX CHOCOLATE UPC:77245111303 NET WT. 14.11 (400 g). Mixed Bag ELITE MINI MIX CHOCOLATE BAR UPC:815871012959 NET WT. 13.75oz (390 g). Mixed bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1121-2022·2022-06-15

    Bone Marrow Biopsy Tray with Lidocaine Hydrochloride Recalled for Temperature Abuse

    McKesson is recalling Bone Marrow Biopsy Trays with Lidocaine due to cGMP deviations from temperature abuse. Product was distributed nationwide.

    Product
    Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1119-2022·2022-06-15

    Intralipid Intravenous Fat Emulsion Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling Intralipid intravenous fat emulsion distributed nationwide due to cGMP deviations involving temperature abuse that could compromise product safety.

    Product
    INTRALIPID — INTRALIPID (I.V. FAT EMULSION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1003-2022·2022-06-15

    Dexmedetomidine vials recalled due to temperature abuse during distribution

    McKesson Medical-Surgical is recalling Dexmedetomidine HCL single-dose vials due to temperature abuse during manufacturing or distribution that may have compromised product quality. No illnesses or injuries have been reported.

    Product
    Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1098-2022·2022-06-15

    Epinephrine injection vials recalled for temperature abuse during distribution

    Epinephrine injection vials are being recalled because they may have been exposed to improper temperatures during distribution, potentially affecting their effectiveness.

    Product
    Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC 04094-933-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1151-2022·2022-06-15

    Pasta Salad with Bacon Recalled Due to Metal Foreign Material

    Dutch Treat Foods, Lipari Old Tyme, and Craftology bacon pasta salad products are recalled due to metal fragments in the bacon. Products were distributed in Michigan.

    Product
    Dutch Treat Foods Sweet Bacon Bowtie Pasta Salad, 10lbs food service case only, UPC 8-81399-00022-8. Lipari Old Tyme Sweet Bacon Bowtie Pasta Salad, 10lbs food service case only, UPC 8-81399-00032-7. Craftology Bacon With Your Bowtie Pasta Salad, 14oz. UPC 8-55034-00650-0; 6 x
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1056-2022·2022-06-15

    Metronidazole Tablets Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Metronidazole 250 mg tablets manufactured by Major Pharma due to temperature deviations during manufacturing that could affect drug potency. Patients should consult their pharmacist or doctor.

    Product
    Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1013-2022·2022-06-15

    FDA Recalls Epinephrine Auto-Injectors Due to Temperature Abuse

    McKesson is recalling 55 packs of epinephrine auto-injectors nationwide due to temperature abuse during manufacturing. This represents a deviation from manufacturing standards.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1264-2022·2022-06-15

    Bulk Peaches from Chile Recalled for Potential Listeria Monocytogenes Contamination

    Brookshire Grocery Co. is recalling 595 cases of bulk peaches from Chile (PLU 4044) due to potential Listeria monocytogenes contamination. The product was distributed in Texas, Arkansas, and Louisiana.

    Product
    yellow flesh bulk peaches product of Chile bulk approximately 16lbs. per case PLU 4044
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1080-2022·2022-06-15

    Revonto dantrolene sodium injection recalled due to temperature abuse during distribution

    McKesson is recalling Revonto (dantrolene sodium injection) due to temperature abuse during storage and distribution affecting 16 cartons distributed nationwide.

    Product
    Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1094-2022·2022-06-15

    Labetalol Hydrochloride Tablets Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Labetalol Hydrochloride Tablets 100 mg due to temperature abuse during manufacturing that may affect drug stability. This Class II recall affects units distributed nationwide.

    Product
    Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1082-2022·2022-06-15

    Prescription Thrombin Product Recalled for Temperature Storage Deviations

    McKesson is recalling RECOTHROM (Thrombin Topical Recombinant) because products were subjected to temperature abuse during storage or distribution, causing a cGMP (manufacturing practice) deviation.

    Product
    RECOTHROM — RECOTHROM (THROMBIN TOPICAL RECOMBINANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2022·2022-06-15

    Sandwich Product Recalled for Potential Insect Filth Contamination

    GRUVIPA S.L. is recalling CB1102052 BOCATA ESPECIAL CASERO'S sandwiches distributed in Florida due to potential insect filth contamination. Consumers should not consume affected products.

    Product
    CB1102052 BOCATA ESPECIAL CASERO'S
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1100-2022·2022-06-15

    Verapamil HCL injection recalled due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Verapamil HCL injection ampules (NDC 04094-011-01) distributed nationwide due to temperature abuse during manufacturing.

    Product
    Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1258-2022·2022-06-15

    Trader Joe's Southwestern Chopped Salad Recalled for Undeclared Pistachio Allergen

    Trader Joe's Southwestern Chopped Salad is recalled because it contains an incorrect master pack with undeclared pistachio allergen. Consumers with pistachio allergies should not consume this product.

    Product
    Trader Joe's Southwestern Chopped Salad Contains: Green Cabbage, Romaine, Cotija Cheese, Roasted Pepitas, Tortilla Strips, Green Onion, Cilantro, and a spicy Southwest Avocado Dressing Best if used by: May 26, 2022 Perishable, Keep Refrigerated Product of USA-Mexico Romaine: Sali
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1153-2022·2022-06-15

    Baked Beans Recall: Metal Contamination in Craftology and Busch's Products

    Craftology and Busch's baked beans are being recalled due to metal contamination in the bacon component. Products were distributed in Michigan.

    Product
    Craftology Where You Bean, Baby? Baked Beans, 14oz. UPC 8-55034-00692-0; 6 x 14oz. per case UPC 8-55034-00691-3 Busch s Baked Beans, 10lbs food service case only, UPC 8-55034-00622-7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1067-2022·2022-06-15

    Levalbuterol tartrate HFA inhalation aerosol recalled for temperature abuse

    Levalbuterol tartrate HFA inhalation aerosol is being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during storage and distribution. The FDA has classified this as a Class II recall.

    Product
    LEVALBUTEROL TARTRATE HFA INHALATION — LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1178-2022·2022-06-15

    Milk chocolate bar recalled nationwide for potential Salmonella contamination

    Elite Popping Rocks Milk Chocolate Bar (UPC 815871010337) is being recalled nationwide due to potential Salmonella contamination. All lots are affected.

    Product
    ELITE POPPING ROCKS MILK CHOCOLATE BAR UPC:815871010337 Net Wt. 3.53 oz (100g). Red packaging.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1076-2022·2022-06-15

    FDA Recalls Proair HFA Albuterol Inhalation Aerosol for Temperature Abuse

    The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.

    Product
    Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1060-2022·2022-06-15

    FDA Recalls Medroxyprogesterone Acetate Injectable Suspension for Temperature Abuse

    McKesson Medical-Surgical recalls 780 vials of medroxyprogesterone acetate injectable suspension nationwide due to temperature exposure during distribution that may affect medication stability.

    Product
    Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1262-2022·2022-06-15

    Valencian Almonds with Truffle Recalled for Foreign Materials

    Valencian Almonds with Truffle distributed in bulk cases are being recalled due to potential foreign materials. The firm-initiated recall affects 60 cases distributed in Oregon.

    Product
    Valencian Almonds with TRUFFLE FS distributed in bulk case, each case contains 2/11 lbs. bags. Net Wt. per case 22 lbs. Product is shelf stable. The label of the bulk case is read in parts: "***Matiz MZ522 ***Valencian Almonds with TRUFFLE FS ***5 KG Skinless*** Net Wt. 352 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1088-2022·2022-06-15

    Levofloxacin 500 mg Tablets Recalled Due to Manufacturing Temperature Abuse

    Mckesson Medical-Surgical is recalling Levofloxacin 500 mg tablets nationwide due to temperature abuse during manufacturing that violated pharmaceutical quality standards.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1031-2022·2022-06-15

    Baxter Sterile Water for Injection recalled due to manufacturing defects

    McKesson is recalling Baxter Sterile Water for Injection USP (2000 mL) distributed nationwide due to temperature abuse during manufacturing that may compromise sterility.

    Product
    STERILE WATER — STERILE WATER (WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1095-2022·2022-06-15

    Bupivacaine Hydrochloride Injection Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride injections distributed nationwide due to manufacturing deviations involving temperature abuse that may have compromised the drug's potency and sterility.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1040-2022·2022-06-15

    FDA Recalls Ipratropium Bromide Inhalation Solution Due to Manufacturing Deviation

    McKesson Medical-Surgical is recalling Ipratropium Bromide Inhalation Solution nationwide due to current good manufacturing practice (cGMP) deviations involving temperature control. The FDA has classified this as a Class II recall.

    Product
    IPRATROPIUM BROMIDE — IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0987-2022·2022-06-15

    B-Complex plus Chromic Chloride injection recall for lack of sterility assurance

    US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.

    Product
    B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1273-2022·2022-06-15

    Zydot Ultimate Blend Detox Drink Recalled for Undeclared Food Coloring and Preservatives

    Zydot Unlimited recalls its Ultimate Blend detox drink due to undeclared food colorings (Y5 and R40) and preservatives on the label. Consumers with allergies to these ingredients should not use the product.

    Product
    Zydot Ultimate Blend The Original Detox Drink Natural Orange Flavor 16 fl. oz. (473 ml) UPC packaged in plastic bottle with lid
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1015-2022·2022-06-15

    Firmagon Injection Recalled Due to Manufacturing Temperature Abuse

    McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.

    Product
    Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1017-2022·2022-06-15

    GlucaGen Glucagon Injection Recalled for Temperature Control Deviations

    GlucaGen (glucagon) injection vials are being recalled due to temperature abuse during manufacturing that may have compromised product stability. The 187 vials were distributed nationwide.

    Product
    GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1030-2022·2022-06-15

    Smiths Medical Spinal Tray Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were distributed nationwide.

    Product
    Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V424000·2022-06-15

    2022 Kenworth T180 ABS warning light malfunction recall

    PACCAR is recalling certain 2022 Kenworth T180 and 2023 Kenworth T280 and Peterbilt 535 vehicles because the ABS warning light may not illuminate during an ABS malfunction, potentially increasing crash risk. Dealers will provide a free software update.

    Product
    PETERBILT — PETERBILT, KENWORTH 535, T180, T280
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0989-2022·2022-06-15

    Homeopathic Ear Drops Recalled Due to Microbial Contamination Risk

    EAR CARE EARACHE DROPS are being recalled nationwide due to potential microbial contamination. Rite Aid is recalling 16,374 bottles of the homeopathic otic product.

    Product
    EAR CARE EARACHE DROPS — EAR CARE EARACHE DROPS (ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1057-2022·2022-06-15

    Promethazine HCl Tablets Recalled Due to Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling Promethazine HCl Tablets, 25 mg, due to temperature deviations during manufacturing that did not comply with current good manufacturing practices. The recall affects 16 cartons distributed nationwide.

    Product
    Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1275-2022·2022-06-15

    Baguette Super recalled for potential insect filth contamination

    GRUVIPA S.L. is recalling CB1101004 and CB1101005 BAGUETTE SUPER products distributed in Florida due to potential insect filth contamination.

    Product
    CB1101004 BAGUETTE SUPER and CB1101005 BAGUETTE SUPER (34 u.)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1104-2022·2022-06-15

    Injectable Pantoprazole Sodium Recalled for Temperature Exposure During Manufacturing

    McKesson Medical-Surgical Inc. is recalling injectable Pantoprazole Sodium for Injection due to manufacturing deviations involving temperature abuse. The nationwide recall affects a 10-vial carton; no illnesses have been reported.

    Product
    Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2022·2022-06-15

    Reliance Synergy Washer/Disinfector fire hazard due to electrical contactor malfunction

    Steris Corporation is recalling Reliance Synergy Washer/Disinfector units due to a malfunctioning electrical contactor that can cause heating elements to overheat, creating a fire risk. Affected units may generate smoke and fire in the drying chamber.

    Product
    Reliance Synergy Washer/Disinfector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1109-2022·2022-06-15

    Pilocarpine Ophthalmic Solution Recalled Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical Inc. is recalling Pilocarpine HCL Ophthalmic Solution due to temperature abuse during manufacturing that may affect product stability. The product was distributed nationwide.

    Product
    Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2022·2022-06-15

    Siemens Artis Icono Angiography Systems Pose Electric Shock Risk

    Siemens Artis icono angiography systems may pose electric shock risk if protective grounding is interrupted. Affected units sold nationwide; users should verify equipment grounding integrity.

    Product
    Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1025-2022·2022-06-15

    Amoxicillin capsules recalled due to temperature exposure during manufacturing

    McKesson Medical-Surgical is recalling Amoxicillin 500mg capsules distributed nationwide due to temperature abuse during manufacturing that may compromise product potency and effectiveness.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2022·2022-06-15

    Medical imaging software measurement accuracy error in Centricity PACS RA1000

    GE Healthcare's Centricity PACS RA1000 medical imaging software may display inaccurate distance and area measurements on magnified or scaled images, potentially affecting diagnostic accuracy.

    Product
    Centricity PACS RA1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0996-2022·2022-06-15

    Topex Benzocaine Topical Anesthetic Recalled for Temperature-Abuse Manufacturing Deviation

    McKesson Medical-Surgical is recalling Topex benzocaine 20% topical anesthetic gel due to cGMP deviations involving temperature abuse during manufacturing. The recall affects 24 bottles distributed nationwide.

    Product
    Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2022·2022-06-15

    Getinge CM320 WUWD Washer Disinfector Installation Verification Issue Recall

    The FDA is recalling 11 Getinge CM320 WUWD washer-disinfectors used for surgical instrument processing. Installation verification was not properly documented or completed, potentially creating risks of electrical shock, burns, and other injuries.

    Product
    Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1084-2022·2022-06-15

    FDA Class II Recall: E-Z-HD Barium Sulfate Oral Suspension Due to Temperature Abuse

    McKesson is recalling E-Z-HD (Barium Sulfate for Oral Suspension) due to temperature deviations during manufacturing. Healthcare providers should stop using the recalled product and contact the manufacturer for lot identification.

    Product
    E-Z-HD — E-Z-HD (BARIUM SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1000-2022·2022-06-15

    Bupivacaine HCl Injection Recalled Due to Temperature Abuse Manufacturing Defect

    Bupivacaine HCl Injection multi-dose vials are being recalled due to temperature abuse during manufacturing. The product was distributed nationwide. Patients should consult their healthcare provider for alternative treatments.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1102-2022·2022-06-15

    Prescription eye ointment recalled for temperature storage deviations

    McKesson Medical-Surgical recalls Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment (120 tubes) nationwide due to temperature storage deviations during manufacturing.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1051-2022·2022-06-15

    Glucagon Emergency Kit Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Glucagon Emergency Kits nationwide due to temperature abuse during manufacturing, which may affect drug efficacy. Patients should contact their healthcare provider.

    Product
    Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0994-2022·2022-06-15

    FDA Class II Recall: Miochol E Intraocular Solution Due to Temperature Exposure

    McKesson is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.

    Product
    MIOCHOL E — MIOCHOL E (ACETYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2022·2022-06-15

    Emergency relief bed recalled for missing UDI and incorrect weight limit label

    Oakworks Inc is recalling PX200 Emergency Relief Beds due to labeling defects. The product label is missing the UDI number and states an incorrect weight capacity of 500 lbs instead of the actual 400 lb limit.

    Product
    PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1023-2022·2022-06-15

    Albuterol Sulfate Inhaler Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling Albuterol Sulfate Inhalation Aerosol HFA due to temperature exposure during manufacturing that caused deviations from manufacturing practice standards. The affected product was distributed nationwide.

    Product
    Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2022·2022-06-15

    Triathlon Tritanium Tibial Components Recalled for Size-Packaging Mismatch

    Howmedica Osteonics is recalling specific lots of Triathlon Tritanium Tibial Components (knee implants) due to a potential mismatch between package labeling and the actual component size contained inside.

    Product
    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1041-2022·2022-06-15

    ClomiPHENE Citrate Tablets 50 mg Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling ClomiPHENE Citrate Tablets 50 mg due to temperature abuse during distribution. The medication was distributed nationwide; patients should contact their healthcare provider for guidance.

    Product
    ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1034-2022·2022-06-15

    FDA Recalls BSS Sterile Irrigating Solution for Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide due to cGMP deviations involving temperature abuse during manufacturing. The recall affects prescription-only ophthalmic solutions.

    Product
    BSS — BSS (BALANCED SALT SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1026-2022·2022-06-15

    Apraclonidine ophthalmic solution recalled for temperature-abuse manufacturing defect

    McKesson Medical-Surgical is recalling 21 bottles of Apraclonidine 0.5% ophthalmic solution due to cGMP deviations involving temperature abuse during manufacturing. The temperature exposure may reduce drug efficacy.

    Product
    APRACLONIDINE — APRACLONIDINE (APRACLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1010-2022·2022-06-15

    Epidural Nerve Block Tray Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling an Epidural Nerve Block Tray (model #182207) distributed nationwide due to temperature abuse during manufacturing that violates cGMP standards. The exposure may compromise device sterility required for safe epidural procedures.

    Product
    Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1072-2022·2022-06-15

    Injectable MethyLPREDNISolone Suspension Recalled Due to Temperature Abuse

    MethyLPREDNISolone Acetate Injectable Suspension (400 mg/10 mL) is recalled due to temperature abuse during storage that may have compromised product quality. Approximately 796 vials were distributed nationwide.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0045-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1022-2022·2022-06-15

    Adrenalin epinephrine vials recalled nationwide due to temperature-abuse deviations

    McKesson Medical-Surgical is recalling Adrenalin (epinephrine) 30 mL vials nationwide due to cGMP deviations involving temperature abuse during manufacturing. Temperature excursions may compromise drug potency.

    Product
    ADRENALIN — ADRENALIN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1075-2022·2022-06-15

    FDA Recalls Mupirocin Ointment Due to Temperature Control Deviations

    Mupirocin Ointment distributed nationwide is being recalled due to temperature abuse violations during manufacturing. Consumers with affected supplies should contact their pharmacy or healthcare provider for guidance.

    Product
    MUPIROCIN — MUPIROCIN (MUPIROCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0995-2022·2022-06-15

    FDA Class II Drug Recall: TOBRADEX Ophthalmic Ointment, Temperature Abuse

    McKesson Medical-Surgical is recalling TOBRADEX ophthalmic ointment nationwide due to cGMP deviations involving temperature abuse. Product distributed between June 1 and September 30, 2021 may be affected.

    Product
    TOBRADEX — TOBRADEX (TOBRAMYCIN AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1093-2022·2022-06-15

    FDA Recalls Prazosin Hydrochloride Capsules Due to Temperature Storage Deviations

    McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage that may affect medication stability.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1271-2022·2022-06-15

    Detox drink recalled for undeclared preservatives and food coloring

    Zydot Ultimate Blend The Original Detox Drink is recalled for undeclared preservatives (potassium sorbate, sodium benzoate) and food coloring R40. The recall involves 1,150 bottles distributed in the USA.

    Product
    Zydot Ultimate Blend The Original Detox Drink Natural Cherry Flavor 16 fl. oz. (473 ml) UPC 754515281439 packaged in plastic bottle with lid
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1235-2022·2022-06-15

    Biliary Electrohydraulic Lithotripter Probe Recalled for Incorrect Product Labeling

    Northgate Technologies is recalling 55 AUTOLITH Touch 1.9F biliary lithotripter probes due to incorrect product labeling. Affected devices were distributed nationwide in Massachusetts.

    Product
    AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0982-2022·2022-06-15

    Ophthalmic Drug Xiidra Recalled for Failed Impurity Specifications

    Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.

    Product
    XIIDRA — XIIDRA (LIFITEGRAST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1228-2022·2022-06-15

    JOBST Compri2 Compression Bandages Recalled for Folding Box Mislabeling

    BSN Medical Inc is recalling JOBST Compri2 and Compri2 lite compression bandages because the folding boxes containing the products are mislabeled. The actual products and immediate packaging are correctly labeled.

    Product
    (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1274-2022·2022-06-15

    Food bars potentially contaminated with insect filth recalled in Florida

    GRUVIPA S.L. is recalling CB1101001 BARRA XXL bars distributed in Florida due to potential contamination with insect filth. Consumers with affected lot codes should discard the product.

    Product
    CB1101001 BARRA XXL
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0988-2022·2022-06-15

    FDA Recalls Teva Alprostadil Injection for Failed Impurity Specifications

    Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.

    Product
    Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2022·2022-06-15

    OTC Antacid E-Z-GAS Recalled for Manufacturing Temperature Control Deviations

    McKesson Medical-Surgical Inc. recalls E-Z-GAS II antacid product distributed nationwide due to cGMP deviations resulting from temperature abuse during manufacturing.

    Product
    E-Z-GAS — E-Z-GAS (ANTACID/ANTIFLATULENT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1101-2022·2022-06-15

    Diphenhydramine HCl oral solution recalled for temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Diphenhydramine HCl oral solution nationwide due to temperature abuse during manufacturing. No illnesses or injuries have been reported.

    Product
    DIPHENHYDRAMINE HYDROCHLORIDE — DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1001-2022·2022-06-15

    Bupivacaine HCl Injection Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0985-2022·2022-06-15

    Xiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications

    Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 0242
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1097-2022·2022-06-15

    Depo-Medrol injectable suspension recalled for manufacturing temperature control deviations

    McKesson Medical-Surgical is recalling Depo-Medrol (methylprednisolone acetate) 80mg/mL injectable suspension due to manufacturing temperature control deviations. The recall affects 177 cartons distributed nationwide.

    Product
    DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1043-2022·2022-06-15

    FDA Recalls Prescription Lidocaine Patch Due to Temperature Exposure

    McKesson Medical-Surgical is recalling Lidocaine Patch 5% nationwide due to temperature abuse during distribution that may have compromised product quality. The FDA classified this as a Class II recall.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1068-2022·2022-06-15

    Prescription Lidocaine Patches Recalled for Temperature-Related Quality Deviations

    Mckesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during distribution that may affect product quality and efficacy. Affected patches were distributed nationwide.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1065-2022·2022-06-15

    Ketoconazole Cream 2% Recalled Due to Manufacturing Temperature Abuse

    McKesson Medical-Surgical is recalling Ketoconazole Cream 2% (60-gram tubes) distributed nationwide due to cGMP deviations involving temperature abuse during manufacturing.

    Product
    KETOCONAZOLE — KETOCONAZOLE (KETOCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1077-2022·2022-06-15

    Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Propofol Injectable Emulsion vials due to cGMP manufacturing deviations involving temperature abuse. No illnesses have been reported.

    Product
    Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0983-2022·2022-06-15

    Xiidra ophthalmic solution recalled for failed impurity and degradation specifications

    Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.

    Product
    Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1048-2022·2022-06-15

    FDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse

    The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.

    Product
    Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1078-2022·2022-06-15

    Propofol Injectable Emulsion Recalled for Temperature Abuse During Manufacture

    McKesson Medical-Surgical is recalling Teva Propofol Injectable Emulsion (200 mg/20 mL, 25-vial cartons) nationwide due to temperature abuse during manufacturing that may affect product quality. A total of 564 cartons were distributed.

    Product
    Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1083-2022·2022-06-15

    FDA Recalls Transderm Scop Scopolamine Transdermal Patches for Temperature Deviation

    McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.

    Product
    TRANSDERM SCOP — TRANSDERM SCOP (SCOPOLAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1021-2022·2022-06-15

    Ipratropium Bromide and Albuterol Sulfate inhalation solution recalled for temperature abuse

    McKesson Medical-Surgical has recalled Ipratropium Bromide and Albuterol Sulfate inhalation solution due to temperature abuse during storage that resulted in cGMP deviations. The nationwide recall affects 56 pouches; no illnesses or injuries have been reported.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1236-2022·2022-06-15

    1.8mm Truss Wire Component Recalled for Product Upgrade

    New Standard Device Inc is recalling 1.8mm truss wires used in the Metalogix Revolution External Plating System to facilitate introduction of stronger 2.0mm wires.

    Product
    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
    Category
    Medical Device
    Distribution
    Distributed nationwide

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