Metformin HCL ER USP 500 Mg recall: Nitrosamine Impurity
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets…
Why was Metformin HCL ER USP 500 Mg 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?
Lots: a) D19C80, F19C39, H19A55, H19D56, I18E0 Exp. 06/30/2020; b) D19A66, E19C15, F19D60 Exp. 06/30/2020; c) E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56 Exp. 06/30/2020; d) E19C11, F19E33, I18E07 Exp. 06/30/2020; e) D19D56, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43 Exp. 06/30/2020; f) HF06618A, HF06718A Exp. 06/30/2020
- Product
- metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets…
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Quantity
- 3703 bottles
- Distribution
- United States
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)