Metformin Hydrochloride Extended-Release Tablets recall: Nitrosamine Impurity
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO…
Why was Metformin Hydrochloride Extended-Release Tablets recalled?
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
MET100201, MET100401 EXP 05/2022
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO…
- Recalling firm
- Nostrum Laboratories Inc
- Quantity
- 20,872 bottles
- Distribution
- Nationwide
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)