Preferred Pharmaceuticals, Inc. recalls Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg

Recalled May 26, 2021 · FDA recall D-0385-2021 · Preferred Pharmaceuticals

Hazard

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day. · FDA Class II

Units

147 bottles (14,700 extended release tablets)

Sold at

Distributed to two physician consignees located in FL.

Description

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Product

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

Manufacturer(s)

Preferred Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →