Why it was recalled
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
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
Lot numbers, UPCs & expiration codes
Lot: R2200232 Exp. 01/2025
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0131-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 29, 2022
- FDA report date
- Jan 25, 2023
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0131-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91228
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lot: R2200232 Exp. 01/2025
- Postal code
- 27703-8446
- Report date
- Jan 25, 2023
- Product type
- Drugs
- Recall number
- D-0131-2023
- Classification
- Class I
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- Unknown
- Termination date
- Feb 22, 2024
- Reason for recall
- Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2023