Metformin Hydrochloride Extended-Release Tablets recall: Nitrosamine Impurity
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas…
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?
Lot MET200601, 07/2022
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas…
- Recalling firm
- Nostrum Laboratories Inc
- Quantity
- 7071 bottles
- Distribution
- Nationwide
- Recall date
- February 10, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)