D-0385-2021 Class II Ongoing
FDA drug recall D-0385-2021 was initiated by Preferred Pharmaceuticals, Inc. on April 28, 2021 and is designated Class II. Reason for recall: CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day. The recall status is ongoing. Affected quantity: 147 bottles (14,700 extended release tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 bottles (14,700 extended release tablets)
Product Description
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
Reason for Recall
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Distribution Pattern
Distributed to two physician consignees located in FL.
Code Information
Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022