Dodex Injectable — Class III drug recall D-0580-2024
Terminated recall by Accord Healthcare, Inc., reported 2024-07-10, distributed nationwide. Subpotent drug: out of specification results
| Recall number | D-0580-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2024-06-18 |
| Classified | 2024-07-02 |
| Reported by FDA | 2024-07-10 |
| Terminated | 2026-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 52,998 |
| Reason classes | potency, specification failure |
| NDC | 16729-0533-08 |
| Lot numbers | M2215870, M2215918, R2200834, R2200835, R2200841, R2200958, R2201044, R2201045, R2201046, R2201047, R2201095, R2201142, R2201143, R2201144 |
| Expiration dates | 2024-06-30, 2024-07-31, 2024-10 |
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
Reason for recall
Subpotent drug: out of specification results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0580-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.