Metformin Hydrochloride Extended-Release Tablets USP recall: Nitrosamine Impurity
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals…
Why was Metformin Hydrochloride Extended-Release Tablets USP recalled?
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
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?
N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
- Product
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals…
- Recalling firm
- Denton Pharma, Inc.
- Quantity
- N/A
- Distribution
- Indiana - Nationwide.
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)