Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
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
Lot numbers, UPCs & expiration codes
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;
Where it was sold
United States including Puerto Rico and Canada
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-0381-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 65,233 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0381-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91657
- Address
- 1009 Slater Rd Ste 210B
- Code information
- 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;
- Postal code
- 27703-8446
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0381-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 65,233 vials
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- United States including Puerto Rico and Canada
- Recall initiation date
- Feb 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2023