Dodex Injectable Cyanocobalamin Injection — Class III drug recall D-0528-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-04-12, distributed nationwide. Sub-potent drug: assay test result below specifications at 9-month timepoint.
| Recall number | D-0528-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-03-29 |
| Classified | 2023-04-06 |
| Reported by FDA | 2023-04-12 |
| Terminated | 2025-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 4,574 cartons |
| Reason classes | potency |
| NDC | 16729-0533-08 |
| Lot numbers | R2200394 |
| Expiration dates | 2024-03 |
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.
Reason for recall
Sub-potent drug: assay test result below specifications at 9-month timepoint.
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-0528-2023. 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.