Time-Cap Labs recall: Nitrosamine Impurity
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7…
Why was Time-Cap Labs recalled?
CGMP Deviations: detection of 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?
M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
- Product
- Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7…
- Recalling firm
- Marksans Pharma Limited
- Quantity
- 368,976 bottles
- Distribution
- Nationwide
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)