Recall D-0528-2023
Description: 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.
Recall D-0528-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0528-2023 |
| Event ID | 91977 |
| Distribution | Nationwide in the USA. |
| Quantity | 4574 cartons |
| Recall Reason | Sub-potent drug: assay test result below specifications at 9-month timepoint. |
| Drug Classification | Class III |
| Drug Code Info | 20230412 |
| Recall Initiation Date | 20230329 |
| Report Date | 20230412 |
| Classification Date | 20230406 |
| Address | 1009 Slater Rd Ste 210B Durham, NC 27703-8446 United States |
| Recalling Firm | Accord Healthcare, Inc. |
| Initial Notification | |
| Similar To |