Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIHydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0339-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIHuman Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0533-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIGlycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIGlycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIGlutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIDexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIDexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIDeoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IICyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0333-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IICyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0330-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IICoenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0411-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IICalcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIBiotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Use, Refrigerate, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0220-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIBETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well. 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-5
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIBETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIBETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0620-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIB-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0212-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-5
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0226-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0538-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0550-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIAlprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugAAA Pharmaceutical, Inc.Class IIIDiscount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.
Labeling: Incorrect or Missing Lot and/or Expiration date.
- 2020-03-11FDA-DrugLupin Pharmaceuticals Inc.Class IIDesoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
Failed Impurities/Degradation Specification; high out of specification results observed
- 2020-03-11FDA-DrugTeva Pharmaceuticals USAClass IIMesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
- 2020-03-04FDA-DrugBreckenridge Pharmaceutical, IncClass IIIZoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
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