Teva Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination scenarios.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg and 1000 mg. The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. The affected products are prescription-only and were distributed throughout the United States, including Puerto Rico.
The specific lots subject to recall are identified by the following codes and expiration dates: Lot 1333338M (exp. 08/2020), Lot 1333339A (exp. 08/2020), and Lot 1354471A (exp. 02/2021). The quantity involved includes 15,329 bottles of the 750 mg strength and 137 bottles of the 1000 mg strength.
Patients and healthcare providers should check their medication for these specific lot numbers and expiration dates. If the medication matches the recalled lots, patients should stop using it and contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
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 (5)
- a) 1333338M
- exp. date 08/2020
- 1333339A
- b) 1354471A
- exp. date 02/2021
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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