D-0382-2023 Class II Terminated
FDA drug recall D-0382-2023 was initiated by Accord Healthcare, Inc. on February 7, 2023 and is designated Class II. Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection. The recall status is terminated (terminated April 22, 2024). Affected quantity: 228,760 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- April 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 228,760 vials
Product Description
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.
Distribution Pattern
United States including Puerto Rico and Canada
Code Information
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;