Metformin HCl Extended Release Tablets USP 500 mg recall: Nitrosamine Impurity
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #…
Why was Metformin HCl Extended Release Tablets USP 500 mg recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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?
E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
- Product
- Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #…
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 99 bottles (9990 Extended Release Tablets)
- Distribution
- Distributed to two physician's offices located in FL.
- Recall date
- November 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)