Reported Jun 24, 2020 · Terminated
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC
PD-Rx Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PD-Rx Pharmaceuticals, Inc. · 727 N Ann Arbor Ave · Oklahoma City, OK · 73127-5822
Is this the product you have?
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 43063-428-30) |
| 2 | 60 tablets (NDC: 43063-428-60) |
| 3 | 90 tablets (NDC: 43063-428-90) |
| 4 | 120 tablets (NDC: 43063-428-98) |
| 5 | 180 tablets (NDC: 43063-428-93) |
| 6 | 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 D19C80, F19C39, H19A55, H19D56, I18E0 Exp. 06/30/2020 2 D19A66, E19C15, F19D60 Exp. 06/30/2020 3 E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56 Exp. 06/30/2020 4 E19C11, F19E33, I18E07 Exp. 06/30/2020 5 D19D56, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43 Exp. 06/30/2020 6 HF06618A, HF06718A Exp. 06/30/2020 - Amount recalled
- 3703 bottles
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
This product could cause temporary or reversible health problems — stop using it.
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