Reported Nov 25, 2020 · Terminated
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.;…
Preferred 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: Preferred Pharmaceuticals, Inc. · 1250 N Lakeview Ave Ste O · Anaheim, CA · 92807-1801
Is this the product you have?
- Metformin HCl Extended Release Tablets USP 500 mg
- Generic forGlucophage XR, Pkg Size 100
- MfgTime-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc
- Lot codes and dates
E0620FExp.12/31/2021G2020M Exp04/30/2022
- Amount recalled
- 99 bottles (9990 Extended Release Tablets)
Where it was sold
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
This product could cause temporary or reversible health problems — stop using it.
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