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)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PD-Rx Pharmaceuticals, Inc.
- Reason for Recall:
- CGMP deviations.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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)
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0560-2023
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