FDA-Drug2021-05-26Class II
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Preferred Pharmaceuticals, Inc.
Hazard
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Sold states
Distributed to two physician consignees located in FL.
Affected count
147 bottles (14,700 extended release tablets)
Manufactured in
1250 N Lakeview Ave Ste O, N/A, Anaheim, CA, United States
Products
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2021Don't want to check this manually?
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