FDAFDA · Food and drugs·Recall number D-0558-2023
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)
Published May 10, 2023 · Recall initiated: April 6, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Distributor
- Nationwide in the US.
- Lot
- Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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