FDAFDA · Food and drugs·Recall number D-0408-2023
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Published March 8, 2023 · Recall initiated: February 7, 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: recalling drug products following an FDA inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SIMVASTATIN
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- United States including Puerto Rico and Canada
- UPC
- 316729156158
- Lot
- Batches: a) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199, Exp. Date 9/30/2023; R2101200, Exp. Date 9/30/2023; R2101355, Exp. Date 10/31/2023; R2200035, Exp. Date 10/31/2023; R2200515, Exp. Date 4/30/2025; R2200514, Exp. Date 4/30/2025; R2200516, Exp. Date 4/30/2025; b) R2200310, Exp Date 9/30/2023; R2101354, Exp. Date 10/31/2023; R2200513, Exp. Date 4/30/2025; R2200768, Exp. Date 5/31/2025;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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