Reported Nov 11, 2020 · Terminated
metformin HCL ER 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 500 mg, a) 30 tablets NDC
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 72789-009-30 |
| 2 | 60 tablets NDC: 72789-009-60 |
| 3 | 90 tablets NDC: 72789-009-90 |
| 4 | 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21 2 A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A45, D20C80 Exp. 12/31/21, G20D46, I20C57 Exp. 04/30/22 3 A20D90, A20E77, A20F69, B20F43 Exp. 07/31/21, C20B14, D20A41 Exp. 12/31/21, I20D94, I20E56, J20A28 Exp. 04/30/22 4 B20B96 Exp. 07/31/21, C20C28, C20E58, D20B17 Exp. 12/31/21, G20D91 Exp. 04/30/22 - Amount recalled
- 1683 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
This product could cause temporary or reversible health problems — stop using it.
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