Why it was recalled
Subpotent drug: out of specification results
Product description
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
Lot numbers, UPCs & expiration codes
Lot# R2200834, R2200835, R2200841, R2200958, Exp 06/30/2024; R2201044 R2201045 R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, Exp 07/31/2024; M2215870, M2215918, Exp 10/2024
Where it was sold
USA Nationwide
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-0580-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 18, 2024
- FDA report date
- Jul 10, 2024
- Quantity
- 52,998
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0580-2024, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 94842
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lot# R2200834, R2200835, R2200841, R2200958, Exp 06/30/2024; R2201044 R2201045 R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, Exp 07/31/2024; M2215870, M2215918, Exp 10/2024
- Postal code
- 27703-8446
- Report date
- Jul 10, 2024
- Product type
- Drugs
- Recall number
- D-0580-2024
- Classification
- Class III
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 52,998
- Termination date
- Feb 12, 2026
- Reason for recall
- Subpotent drug: out of specification results
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2024