Recalls / Class I
Class ID-0131-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot: R2200232 Exp. 01/2025
Why it was recalled
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-11-29
- FDA classified
- 2023-01-13
- Posted by FDA
- 2023-01-25
- Terminated
- 2024-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0131-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.