Metformin HCl Extended Release Tablets recalled over manufacturing violations
- Recall date
- June 17, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Preferred Pharmaceuticals, Inc. recalls Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc.,…
- Recall number
- D-1364-2020
- FDA classification
- Class II
- Brand / firm
- Preferred Pharmaceuticals, Inc.
- Sold / distributed
- Product was distributed to two medical clinics located in FL.
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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 Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
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