Recalls / Class II
Class IID-0558-2023
Product
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)
- Affected lot / code info
- Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23
Why it was recalled
CGMP deviations.
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 37 bottles
- Distribution pattern
- Nationwide in the US.
Timeline
- Recall initiated
- 2023-04-06
- FDA classified
- 2023-05-01
- Posted by FDA
- 2023-05-10
- Terminated
- 2024-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0558-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.