Class II
Ongoing
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
This recall is currently active, issued May 26, 2021. It was issued by Preferred Pharmaceuticals, Inc..
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- April 28, 2021
- Posted
- May 26, 2021
- Recall Number
- D-0385-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 147 bottles (14,700 extended release tablets)
- Firm Location
- Anaheim, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Distribution
Distributed to two physician consignees located in FL.
Lot / Code Info
Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
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