Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-06-17FDA-DrugMontana Compounding PharmacyClass IIGlutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- 2015-06-17FDA-DrugMontana Compounding PharmacyClass IIGlutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- 2015-06-17FDA-DrugMontana Compounding PharmacyClass IIBimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- 2015-06-17FDA-DrugMontana Compounding PharmacyClass IIAvastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- 2015-06-17FDA-DrugMontana Compounding PharmacyClass IIAlprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- 2015-06-17FDA-DrugMontana Compounding PharmacyClass IIAlprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- 2015-06-17FDA-DrugValeant Pharmaceuticals North America LLCClass IINifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
- 2015-06-10FDA-DrugSandoz, IncClass IIICetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
- 2015-06-10FDA-DrugFresenius Kabi USA, LLCClass IIKABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.
Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
- 2015-06-10FDA-DrugMedtech Products, Inc.Class IISUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433
Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.
- 2015-06-10FDA-DrugTeva Pharmaceuticals USAClass IIZebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
Failed Dissolution Specifications: OOS result during stability testing
- 2015-06-10FDA-DrugMylan Lab IncClass IIMycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.
Failed Dissolution Specifications: Low out of specification dissolution results.
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIDMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugBlenheim Pharmacal, Inc.Class IIClarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
- 2015-06-03FDA-DrugBlenheim Pharmacal, Inc.Class IICaptopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
- 2015-06-03FDA-DrugHospira Inc.Class ILACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIVITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IISODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IISODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IISODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IISODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IINANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IINANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIHYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIHYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIHYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIGLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIGLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
- 2015-06-03FDA-DrugAdvanced Physician Solutions, Inc.Class IIESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Lack of Assurance of Sterility
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