D-0558-2023 Class II Terminated
FDA drug recall D-0558-2023 was initiated by PD-Rx Pharmaceuticals, Inc. on April 6, 2023 and is designated Class II. Reason for recall: CGMP deviations. The recall status is terminated (terminated April 30, 2024). Affected quantity: 37 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 10, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- April 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 bottles
Product Description
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
Reason for Recall
CGMP deviations.
Distribution Pattern
Nationwide in the US.
Code Information
Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23