Reported Jul 1, 2020 · Terminated
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 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?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 30 tablets (NDC 72789-009-30) |
| 2 | 60 tablets (NDC 72789-009-60) |
| 3 | 90 tablets (NDC 72789-009-90) |
| 4 | 180 tablets (NDC 72789-009-93) |
| 5 | 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127 |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020 2 I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020 3 I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020 4 I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. 12/31/2020 5 XP9004 Exp. 12/31/2020 - Amount recalled
- 1969 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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