Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIHCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIHCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIGlutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIGlutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIGlucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIGAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIDexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IICalm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IICalcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIBiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIBiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIBiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIB-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/ml). Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIBCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIAscorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIAmino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugTri-Coast PharmacyClass IIAmino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
Lack of Assurance of Sterility
- 2017-01-11FDA-DrugApotex Corp.Class IITorsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01
CGMP Deviations
- 2017-01-11FDA-DrugApotex Corp.Class IITorsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01
CGMP Deviations
- 2017-01-11FDA-DrugGentell, IncClass IIGentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
CGMP Deviations
- 2017-01-11FDA-DrugGentell, IncClass IIGentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007
CGMP Deviations
- 2017-01-04FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IIIVirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- 2017-01-04FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IIIVirt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- 2017-01-04FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IIIExtra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- 2017-01-04FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IIIVirt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- 2017-01-04FDA-DrugCipher Pharmaceuticals US LLCClass IIIINOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
- 2017-01-04FDA-DrugSandoz IncorporatedClass IINadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
- 2017-01-04FDA-DrugCare-Tech Laboratories, Inc.Class IIITechni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139
Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
- 2017-01-04FDA-DrugRaritan Pharmaceuticals, Inc.Class IICVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639
CGMP Deviations
- 2017-01-04FDA-DrugRaritan Pharmaceuticals, Inc.Class IIKids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639
CGMP Deviations
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