FDA-Drug2020-07-08Class II
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
Preferred Pharmaceuticals, Inc.
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Sold states
Product was distributed to two medical clinics located in FL.
Affected count
144 bottles
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, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1364-2020Don't want to check this manually?
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