Class II
Terminated
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60
- Company
- Pd-Rx Pharmaceuticals, Inc.
- Recall Initiated
- October 6, 2020
- Posted
- November 11, 2020
- Recall Number
- D-0060-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 125 bottles
- Firm Location
- Oklahoma City, OK, United States
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Distribution
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Lot / Code Info
Lots: a) A20A97, B20D25 Exp. 04/30/21, B20D69, C20B95, C20D60, E20A50 Exp. 07/31/21, E20D37, E20D73 Exp. 03/31/22, J19F04 Exp. 01/31/21; b) C20C15 Exp. 07/31/21, F20A14 Exp. 03/31/22, L19C15 Exp. 04/30/21
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