The Recall Desk

Archive

November 2019 recalls

944 recalls were announced in November 2019.

What the numbers show

Critical
50
Severe
405
High
251
Moderate
213
Low
25

Of the 944 recalls this month scored against our rubric, 5% are Critical, 43% are Severe.

601–700 of 944

  • SevereFDA (Drugs)·D-0253-2020·2019-11-13

    Red Mountain Compounding Recalls Testosterone Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Testosterone Half Ultra 125mg/mL due to a lack of assurance of sterility.

    Product
    S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2020·2019-11-13

    Red Mountain Compounding Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific vials of Magnesium Sulfate Injection because the FDA determined there is a lack of assurance of sterility.

    Product
    S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2020·2019-11-13

    Red Mountain Compounding Recalls S-Ascorbic/Glutathione Ophthalmic Solution

    Red Mountain Compounding Pharmacy is recalling S-Ascorbic/Glutathione 1.25/1.25% Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2020·2019-11-13

    Red Mountain Compounding Recalls Testosterone Propionate Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Testosterone Propionate 100mg/mL in sesame oil because the product lacks assurance of sterility.

    Product
    S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0213-2020·2019-11-13

    Red Mountain Compounding Recalls S-DMPS Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-DMPS 50mg/ml injection vials because the FDA identified a lack of assurance of sterility.

    Product
    S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2020·2019-11-13

    Red Mountain Compounding Recalls S-Testosterone Ultra Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Testosterone Ultra 250mg/ml vials because the product lacks assurance of sterility.

    Product
    S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0171-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Walmart-branded Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0247-2020·2019-11-13

    Red Mountain Compounding Recalls S-Pyridoxine HCL Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Pyridoxine HCL (B6) vials because the product lacks assurance of sterility.

    Product
    S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's is recalling Ranitidine Tablets because an NDMA impurity was detected. Consumers should stop using the product and return it to the pharmacy.

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0242-2020·2019-11-13

    Red Mountain Compounding Recalls S-Nandrolone Decanoate Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Nandrolone Decanoate injections due to a lack of assurance of sterility. The affected lot is distributed nationwide.

    Product
    S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Capsules Due to NDMA Impurity

    Dr. Reddy's is recalling Ranitidine Hydrochloride capsules because of CGMP deviations and the presence of NDMA impurity.

    Product
    RANITIDINE HYDROCHLORIDE — RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0262-2020·2019-11-13

    Red Mountain Compounding Recalls S-Estradiol Cypionate Injections Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections because the FDA identified a lack of assurance of sterility.

    Product
    S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0276-2020·2019-11-13

    Baxter Prismaflex Control Unit Recalled for Communication Error Alarms

    Baxter Healthcare is recalling Prismaflex Control Units with software versions below 7.21 because communication error alarms may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0201-2020·2019-11-13

    Red Mountain Compounding Recalls S-Atropine Ophthalmic Solution Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Atropine 0.01% Ophthalmic Solution because the agency could not ensure the product was sterile.

    Product
    S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0224-2020·2019-11-13

    Red Mountain Compounding Recalls S-Glutathione Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Glutathione 200mg/mL vials due to a lack of assurance of sterility.

    Product
    S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0101-2020·2019-11-13

    Golden Dragon Almond Cookies Recalled for Undeclared Milk

    Golden Dragon Fortune Cookies Co Inc is recalling Golden Dragon Almond Cookies due to undeclared milk. The recall covers 500 boxes distributed in Chicago, IL.

    Product
    Golden Dragon Almond Cookies in 5 lbs. box, each 5 lbs. box contains 5, 100 count bags, UPC on box and inner bag: 0 80005 23031 2
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0199-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Ascorbic Acid Vials for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling 81 vials of S-Ascorbic Acid 500mg/mL due to a lack of assurance of sterility.

    Product
    S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0100-2020·2019-11-13

    Cellect and Essentials Factor Multi-Mineral Supplement Recalled for Arsenic and Lead

    Images Unlimited Products is recalling Cellect and Essentials Factor multi-mineral supplements due to unsafe levels of arsenic and lead.

    Product
    CELLECT brand and ESSENTIALS FACTOR Cell Synergy brand Unflavored Powdered Mix Multi-Mineral & Vitamin Supplement NET WT. Approximately 20.4 OZ (1.28 LB) 579g in white plastic bottles
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2020·2019-11-13

    Red Mountain Compounding Recalls S-Calm Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Calm Injection vials because the FDA identified a lack of assurance of sterility.

    Product
    S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2020·2019-11-13

    Red Mountain Compounding Recalls S-MIC 25/50/50 B12A Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC 25/50/50 B12A 5mg/ml solution due to a lack of assurance of sterility.

    Product
    S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0271-2020·2019-11-13

    Red Mountain Compounding Recalls S-Methylcobalamin Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Methylcobalamin injections due to a lack of assurance of sterility. The affected vials were distributed nationwide.

    Product
    S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0278-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0217-2020·2019-11-13

    Red Mountain Compounding Recalls S-Edetate Calcium Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Edetate Calcium 300mg/mL injection vials because the FDA identified a lack of assurance of sterility.

    Product
    S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC/B12/Carnitine Injection for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-MIC/B12(C)/Carnitine injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA.

    Product
    S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s0709
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2020·2019-11-13

    Red Mountain Compounding Recalls S-Amitriptyline Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Amitriptyline 10mg/mL injection vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0279-2020·2019-11-13

    Baxter Prismaflex Control Unit Software Recall for Therapy Interruption Risk

    Baxter is recalling Prismaflex Control Units with software below version 7.21 due to communication errors that may interrupt therapy or cause blood loss.

    Product
    Prismaflex Control Unit, software versions below 7.21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0170-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0221-2020·2019-11-13

    Red Mountain Compounding Recalls Ophthalmic Gel Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling a specific lot of ophthalmic gel because the FDA determined there is a lack of assurance of sterility.

    Product
    S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0185-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because an NDMA impurity was detected. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0172-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0296-2020·2019-11-13

    Red Mountain Compounding Recalls S-TRIMIX Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TRIMIX injection vials because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

    Product
    S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0349-2020·2019-11-13

    ICU Medical Recalls Lactated Ringer's Injection Due to Particulate Matter

    ICU Medical is recalling 389,808 bags of Lactated Ringer's Injection due to the presence of particulate matter. The affected product was distributed nationwide.

    Product
    LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0178-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of NDMA impurity. The product was distributed to major distributors throughout the United States.

    Product
    Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0184-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 150 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0245-2020·2019-11-13

    Red Mountain Compounding Recalls S-Procaine HCL 1% Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Procaine HCL 1% Buffered MDV vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2020·2019-11-13

    Red Mountain Compounding Recalls S-MIC Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/mL B12 1mg/mL MDV Injection Solution vials because of a lack of assurance of sterility.

    Product
    S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Dexpantenol Injection Vials

    Red Mountain Compounding Pharmacy is recalling S-Dexpantenol injection vials due to a lack of assurance of sterility.

    Product
    S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-MIC Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-MIC 25/50/50mg/ml Cyanocobalamin 1mg/ml MDV Solution due to a lack of assurance of sterility.

    Product
    S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2020·2019-11-13

    Red Mountain Compounding Recalls Lidocaine Syringes Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCL 2% inhalation solution syringes due to a lack of assurance of sterility.

    Product
    S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2020·2019-11-13

    Red Mountain Compounding Recalls S-QUADMIX Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-QUADMIX injection vials because the product lacks assurance of sterility.

    Product
    S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2020·2019-11-13

    Red Mountain Compounding Recalls S-E2/TEST CYP Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION vials due to a lack of assurance of sterility.

    Product
    S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2020·2019-11-13

    Dr. Reddy's Recalls Ranitidine Tablets Due to NDMA Impurity

    Dr. Reddy's Laboratories is recalling Ranitidine Tablets 75 mg because of the presence of the NDMA impurity.

    Product
    Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0293-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls S-Vit B Complex Injection Solution

    Red Mountain Compounding Pharmacy is recalling S-Vit B Complex Injection Solution vials due to a lack of assurance of sterility.

    Product
    S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2020·2019-11-13

    Red Mountain Compounding Recalls Potassium Chloride Injection Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of Potassium Chloride Injection because the FDA identified a lack of assurance of sterility.

    Product
    S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2020·2019-11-13

    Red Mountain Compounding Recalls S-HCG 3000 U/ML Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-HCG 3000 U/ML vials because the FDA determined there is a lack of assurance of sterility.

    Product
    S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2020·2019-11-13

    Red Mountain Compounding Recalls Sterility-Compromised CYP/PROP Vials

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in sesame oil due to a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2020·2019-11-13

    Red Mountain Compounding Recalls S-HCG Injections Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling 81 vials of S-HCG 1200U/ML injection solution because the product lacks assurance of sterility.

    Product
    S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0256-2020·2019-11-13

    Red Mountain Compounding Recalls S-Vit A Palmitate Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-Vit A Palmitate 50,000 IU/mL corn oil due to a lack of assurance of sterility.

    Product
    S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0288-2020·2019-11-13

    Red Mountain Compounding Pharmacy Recalls Sterility-Compromised CYP/PROP Vials

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP/PROP 160/40MG/ML MDV in Ethyl Oleate due to a lack of assurance of sterility.

    Product
    S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0234-2020·2019-11-13

    Red Mountain Compounding Recalls Lidocaine Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Lidocaine HCl 1% vials because the FDA identified a lack of assurance of sterility.

    Product
    S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0121-2020·2019-11-13

    Jumbo Foods Recalls Tuscan Sun Chicken Salad Sandwiches for Listeria Risk

    Jumbo Foods is recalling Tuscan Sun brand chicken salad sandwiches due to a potential for contamination with Listeria monocytogenes.

    Product
    Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01413 6. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior selling to consu
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0215-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled for Detector Fall Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2020·2019-11-13

    Red Mountain Compounding Recalls S-Cyanocobalamin Injections Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Cyanocobalamin 1,000 mcg/mL injection solution because the product lacks assurance of sterility.

    Product
    S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0218-2020·2019-11-13

    Red Mountain Compounding Recalls S-Estradiol Cypionate Injections for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-Estradiol Cypionate injections due to a lack of assurance of sterility.

    Product
    S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass vials, Rx Only, Red Mountain Compounding RX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0172-2020·2019-11-13

    Medtech Rosa Brain 3.0 Neurosurgical Device Recalled for Trajectory Errors

    Medtech SAS is recalling 93 Rosa Brain 3.0 neurosurgical devices because the instrument holder may send tools on incorrect trajectories, potentially leading to improper device placement.

    Product
    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of inst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0203-2020·2019-11-13

    Red Mountain Compounding Recalls S-Atropine 0.5% Ophthalmic Solution

    Red Mountain Compounding Pharmacy is recalling S-Atropine 0.5% ophthalmic solution due to a lack of assurance of sterility.

    Product
    S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0169-2020·2019-11-13

    Azuma Foods Recalls Frozen Saba Misozuke for Listeria Risk

    Azuma Foods International is recalling 8 cases of Frozen Saba Misozuke (seasoned Mackerel) distributed in Hawaii due to presumptive positive test results for Listeria monocytogenes.

    Product
    Frozen Saba Misozuke; (seasoned Mackerel) Product # 51108, Not for Retail 12 pkg/5pc(1.76lbs./800g)/ case Distributed by: Azuma Foods International, Inc., U.S.A. Hayward, CA Product of Thailand
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0350-2020·2019-11-13

    ICU Medical Recalls Sodium Chloride Injection Due to Particulate Matter

    ICU Medical Inc is recalling 0.9% Sodium Chloride Injection USP bags because of the presence of particulate matter in the solution.

    Product
    0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0166-2020·2019-11-13

    Azuma Foods Recalls Frozen Ika Popo Due to Listeria Risk

    Azuma Foods International Inc is recalling specific lots of Frozen Ika Popo (Sugata Yaki) in Hawaii due to potential Listeria monocytogenes contamination.

    Product
    Frozen Ika Popo (Sugata Yaki); Product # 51106 16 pkg/0.46 lbs (210g)/case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0127-2020·2019-11-13

    Schwartz Brothers Bakery Recalls Lemon Dessert Bars for Undeclared Egg

    Schwartz Brothers Bakery is recalling 24 packages of Lemon Dessert Bars due to an undeclared egg allergen. The product was distributed in Washington.

    Product
    Lemon Dessert Bars packaged under Schwartz Brothers Bakery brand in a 11.6 oz (328g), kraft packaging with UPC 7 17887 65163 7. The label is read in parts: "***LEMON DESSERT BARS*** Contains Milk, Soy, Wheat ***May Contain Eggs and Tree Nuts*** NET WT 11.6 OZ ***Produced By Sc
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0281-2020·2019-11-13

    GE Healthcare Recalls Giraffe OmniBed Carestation CS1 Due to Fastener Risk

    GE Healthcare is recalling 59 Giraffe OmniBed Carestation CS1 devices because fasteners may be under-torqued, posing a risk that the canopy could detach and fall.

    Product
    Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled man
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0168-2020·2019-11-13

    Azuma Foods Recalls Salmon Misozuke Due to Listeria Risk

    Azuma Foods International is recalling Salmon Misozuke products due to potential Listeria monocytogenes contamination. The recall affects 38 cases distributed in Hawaii.

    Product
    Salmon Misozuke; Seasoned Atlantic Salmon Product # 51104; Not For retail 10 pkg/5 pc(2.75 lbs./1.25 kg)/case Distributed by: Azuma Foods International, Inc., U.S.A. Hayward, CA 64545 Product of Thailand
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0123-2020·2019-11-13

    Jumbo Foods Recalls Tuscan Sun Chipotle Chicken Salad Sandwiches

    Jumbo Foods is recalling Tuscan Sun brand Chipotle Chicken Salad sandwiches due to a potential for contamination with Listeria monocytogenes.

    Product
    Chipotle Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g). UPC 0 43701 01415 0. Product was distributed frozen or refrigerated (fresh) to stores. Frozen product is not sold directly to consumers and it will be thawed by stores prior selling
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0252-2020·2019-11-13

    Red Mountain Compounding Recalls S-TEST CYP Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling specific lots of S-TEST CYP 100mg/ml vials because the FDA identified a lack of assurance of sterility.

    Product
    S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0282-2020·2019-11-13

    Red Mountain Compounding Recalls S-TEST CYP Vials Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling S-TEST CYP 25mg/ml vials nationwide due to a lack of assurance of sterility.

    Product
    S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0132-2020·2019-11-13

    Pride of Iowa Recalls Market Choice Monster Cheeseburgers Due to Metal Contamination

    Pride of Iowa Sandwiches, Inc. is recalling Market Choice Monster Cheeseburgers because the beef patty ingredient was potentially contaminated with foreign metal material.

    Product
    Market Choice Monster Cheeseburger, Net Wt. 9.1 oz individually wrapped in plastic, packaged 12 count per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0342-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 25,840 Grab n Go Opti VIPR systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2020·2019-11-13

    Medtronic Recalls MiniMed Model 500 Remote Controls for Security Vulnerability

    Medtronic is recalling MiniMed Model 500 Remote Controls used with the MiniMed 508 Insulin Pump due to a potential security vulnerability.

    Product
    Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2020·2019-11-13

    Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard

    Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.

    Product
    Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2020·2019-11-13

    Argon Medical Devices Septishield II Recalled for Potential Sterility Loss

    Argon Medical Devices is recalling Septishield II products because an incomplete seal may cause a loss of sterility.

    Product
    Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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