D-0060-2021 Class II Terminated
FDA drug recall D-0060-2021 was initiated by PD-Rx Pharmaceuticals, Inc. on October 6, 2020 and is designated Class II. Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) The recall status is terminated (terminated October 22, 2021). Affected quantity: 125 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 11, 2020
- Initiation Date
- October 6, 2020
- Termination Date
- October 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 bottles
Product Description
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)
Distribution Pattern
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Code Information
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