Drug recall D-0382-2023

Class II Terminated reported Mar 8, 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

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