Drug recall D-0382-2023
Product
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
Lots and codes
Batches: R2101282, Exp. Date 9/30/2023; R2101600,Exp. Date 11/30/2024; R2200002, R2200028, R2200116, R2200142, R2200152, Exp. Date 12/31/2024; R2200165, R2200190, Exp. Date 1/31/2025; R2201042, Exp. Date 7/31/2025;
Recall details
- Recalling firm
- Accord Healthcare, Inc., Durham, NC
- Quantity
- 228,760 vials
- Distribution
- United States including Puerto Rico and Canada
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2023
- Terminated
- April 22, 2024
Related products
- Daptomycin – drug information
- NDC 16729-435 Daptomycin · Daptomycin 500 mg/10mL · Accord Healthcare Inc.