Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratori
Summary
The FDA issued a Class II for Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX o by Teva Pharmaceuticals USA Inc. Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit..
Details
Source
Drug Recall
External ID
D-0441-2023
Action Date
2023-03-15
Status
Terminated
Category
drug
Product Description
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Lot/Code Info: Lot #: 1410946A; Exp. 06/2023
Quantity Affected: 12,044 Bottles
Reason for Recall
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
CA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-22
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA Inc have FDA actions?
Teva Pharmaceuticals USA Inc has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0441-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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