Time-Cap Labs recall: Nitrosamine Impurity
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7…
Why was Time-Cap Labs recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
XP9004, exp 12/2020
- Product
- Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7…
- Recalling firm
- Marksans Pharma Limited
- Quantity
- 11279 bottles
- Distribution
- Nationwide
- Recall date
- July 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)