FDA-Drug2020-11-25Class II
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Sold states
Distributed to two physician's offices located in FL.
Affected count
99 bottles (9990 Extended Release Tablets)
Manufactured in
1250 N Lakeview Ave Ste O, N/A, Anaheim, CA, United States
Products
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2021Don't want to check this manually?
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