FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specifications; exceeded specification at the 9 hour time point
- Published
- June 24, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.
by Allegiant Health
- Reason
- CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
- Published
- June 24, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03
by Baxter Healthcare Corp
- Reason
- Subpotent Drug; out of specification results for heparin raw material
- Published
- June 17, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
by Akorn, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 17, 2015
- Distribution
- Nationwide
View recall →
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 →
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.
Read the full medical disclaimer.