Metformin Extended-Release Tablets Recalled for Excess NDMA Contamination
Teva Pharmaceuticals is recalling Metformin hydrochloride Extended-Release Tablets (1000 mg) due to CGMP deviations that resulted in NDMA contamination exceeding the Acceptable Daily Intake Limit. The recall affects 12,044 bottles distributed in California.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for detected NDMA contamination exceeding the Acceptable Daily Intake Limit. No illnesses or injuries are reported in the source. NDMA is a known risk-of-harm substance, meeting the High severity criterion for products where injury has not yet been reported.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Metformin hydrochloride Extended-Release Tablets, 1000 mg (NDC 00591-2720-60) due to Current Good Manufacturing Practice (CGMP) deviations. Manufacturing issues allowed N-Nitrosodimethylamine (NDMA) to accumulate in affected batches at levels exceeding the FDA's Acceptable Daily Intake Limit.
The recall affects 12,044 bottles distributed in California. The affected lot is #1410946A with an expiration date of June 2023.
Patients taking this medication should contact their pharmacist or healthcare provider for guidance. Do not stop taking metformin without medical direction, as it is prescribed for managing blood sugar in diabetes. Healthcare providers may recommend switching to an alternative source of metformin or an alternative medication while this issue is resolved.
The recalled product
- Product
- 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
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug
- Hazard
- Affected units
- 12,044
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1410946A
- Exp. 06/2023
Distribution
Distributed in 1 state:
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