# FDA recall D-0580-2024

> **Accord Healthcare, Inc.** · Class III · drug recall initiated 2024-06-18.

## 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

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0580-2024
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-06-18
- **Report date:** 2024-07-10
- **Termination date:** 2026-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0580-2024

## Citation

> AI Analytics. FDA recall D-0580-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0580-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*