Drug product
Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.
D-0528-2023
Product summary
- Event
- Event 91977
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4574 cartons
- Official record key
drug-enforcement:D-0528-2023
Official wording
Reason: Sub-potent drug: assay test result below specifications at 9-month timepoint.
Code information: Lot #: R2200394 Exp. 03/2024
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Sub-potent drug: assay test result below specifications at 9-month timepoint.