FDAFDA · Food and drugs·Recall number D-0405-2023
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; 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
- ROSUVASTATIN
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- United States including Puerto Rico and Canada
- UPC
- 316729285155
- Lot
- Batches: a) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2004957, Exp. Date 8/31/2023; P2004958, Exp. Date 8/31/2023; P2004959, Exp. Date 8/31/2023; P2005252, Exp. Date 9/30/2023; P2006607, Exp. Date 11/30/2023; P2101368, Exp. Date 2/29/2024; P2101777, Exp. Date 2/29/2024; P2102224, Exp. Date 3/31/2024; P2104397, Exp. Date 6/30/2024; P2104395, Exp. Date 6/30/2024; P2104398, Exp. Date 6/30/2024; P2105120, Exp. Date 7/31/2024; P2204835, Exp. Date 7/31/2025; P2204834, Exp. Date 7/31/2025; P2204837, Exp. Date 7/31/2025; P2205832, Exp. Date 9/30/2025; P2205833, Exp. Date 9/30/2025;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.