Recalls / Class III
Class IIID-0580-2024
Product
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
- Affected lot / code info
- 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
Why it was recalled
Subpotent drug: out of specification results
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
- 52,998
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-06-18
- FDA classified
- 2024-07-02
- Posted by FDA
- 2024-07-10
- Terminated
- 2026-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0580-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.