Status
Terminated
Drug Enforcement D-0381-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Classification
Class II
Report Date
March 8, 2023
Termination Date
April 22, 2024
Product Information
- Product description
- Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Product quantity
- 65,233 vials
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- United States including Puerto Rico and Canada
Location & Firm
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Address
-
1009 Slater Rd Ste 210B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0381-2023
- Event ID
- 91657
- Recall initiation date
- February 7, 2023
- Center classification date
- March 2, 2023
- Code info
- Batches: a) R2101274, Exp. Date 9/30/2023; R2200161, Exp. Date 1/31/2025; R2200506, Exp. Date 1/31/2025; R2200697, Exp. Date 4/30/2025; R2201107, Exp. Date 7/31/2025; b) R2101471, Exp. Date 9/30/2023; R2200588, Exp. Date 4/30/2025; R2201333, Exp. Date 7/31/2025; R2201361, Exp. Date 8/31/2025;
- More code info
- —