Metformin HCL E/R 500 mg recall: Nitrosamine Impurity
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Why was Metformin HCL E/R 500 mg 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?
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?
Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
- Product
- Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
- Recalling firm
- Direct Rx
- Quantity
- 88 bottles
- Distribution
- FL
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)