Recalls / Class II
Class IID-0560-2023
Product
Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
- Affected lot / code info
- Lots: a) G22B32, D22B92, D22F82, Exp. 06/30/23; G22F41, J22F25, L22C14, Exp. 01/31/24; D22B92, D22F82 Exp. 06/30/23; B22A12, Exp. 03/31/23 b) H22A32, I22E83, J22E94, K22E34 Exp. 01/31/24; C22F31, D22G16, E22D75, F22E06, Exp. 06/30/23; L21E09, B22C61, Exp. 01/31/23.
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
- 520 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-0560-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.