Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Product description
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.
Lot numbers, UPCs & expiration codes
Batches: R2101372, R2101397, R2101404, Exp. Date 4/30/2023; R2200264, R2200270, Exp. Date 8/31/2023; R2200382, Exp. Date 9/30/2023; R2200849, Exp. Date 12/31/2023; R2201017, R2201138, Exp. Date 1/31/2024; R2201249, Exp. Date 2/29/2024
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-0413-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 48,089 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0413-2023, 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: R2101372, R2101397, R2101404, Exp. Date 4/30/2023; R2200264, R2200270, Exp. Date 8/31/2023; R2200382, Exp. Date 9/30/2023; R2200849, Exp. Date 12/31/2023; R2201017, R2201138, Exp. Date 1/31/2024; R2201249, Exp. Date 2/29/2024
- Postal code
- 27703-8446
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0413-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 48,089 cartons
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.
- 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