FDA Recall
Terminated
Historical recordClass II
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 17, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
by Montana Compounding Pharmacy
- Reason
- Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
- Published
- June 17, 2015
- Distribution
- MT and ND
View recall →
FDA Recall
Terminated
Historical recordClass II
Nifedipine 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.
by Valeant Pharmaceuticals North America LLC
- Reason
- Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
- Published
- June 17, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cetirizine 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
by Sandoz, Inc
- Reason
- Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
- Published
- June 10, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
KABIVEN [(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.
by Fresenius Kabi USA, LLC
- Reason
- Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids
- Published
- June 10, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433
by Medtech Products, Inc.
- Reason
- 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.
- Published
- June 10, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zebeta¿ (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
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications: OOS result during stability testing
- Published
- June 10, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mycophenolic 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.
by Mylan Lab Inc
- Reason
- Failed Dissolution Specifications: Low out of specification dissolution results.
- Published
- June 10, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
by Hospira Inc.
- Reason
- Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
- Published
- June 3, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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