MetFORMIN HCL ER 500 mg recalled over manufacturing violations
- Recall date
- June 5, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- PD-Rx Pharmaceuticals, Inc. recalls metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-0…
- Recall number
- D-1333-2020
- FDA classification
- Class II
- Brand / firm
- PD-Rx Pharmaceuticals, Inc.
- Sold / distributed
- United States.
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127
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