FDA Recall
Terminated
Historical recordClass II
Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass I
NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent Drug
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent Drug
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30
by Cardinal Health Inc.
- Reason
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Published
- June 2, 2021
- Distribution
- Multiple states
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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