Drug recall D-0060-2021
Product
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
Reason for recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Lots and codes
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
Recall details
- Recalling firm
- PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK
- Quantity
- 125 bottles
- Distribution
- AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 6, 2020
- Terminated
- October 22, 2021
Related products
- Metformin Hydrochloride Extended Release – drug information
- NDC 43063-902 Metformin Hydrochloride Extended Release · Metformin Hydrochloride 750 mg/1 · PD-Rx Pharmaceuticals, Inc.