Drug 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
D-0580-2024
Product summary
- Event
- Event 94842
- Status
- Terminated
- Classification
- Class III
- Quantity
- 52,998
- Official record key
drug-enforcement:D-0580-2024
Official wording
Reason: Subpotent drug: out of specification results
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
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent