Status
Terminated
Drug Enforcement D-0131-2023
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Classification
Class I
Report Date
January 25, 2023
Termination Date
February 22, 2024
Product Information
- Product description
- Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
- Product quantity
- Unknown
- Reason for recall
- Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
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-0131-2023
- Event ID
- 91228
- Recall initiation date
- November 29, 2022
- Center classification date
- January 13, 2023
- Code info
- Lot: R2200232 Exp. 01/2025
- More code info
- —