Class III · Lower riskRecall completed
Dodex Injectable Cyanocobalamin Injection
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: R2200394 Exp. 03/2024
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Sub-potent drug: assay test result below specifications at 9-month timepoint.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byIntas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 foreign manufacturer
| Distributed by / for | Accord Healthcare, Inc., Durham, NC 27703 |
| NDC | 16729-533-08 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Accord Healthcare, Inc. |
| Distribution | Nationwide in the USA. |
| Quantity | 4574 cartons |
| Recall initiated | 2023-03-29 |
| Report date | 2023-04-12 |
| Recall completed | 2025-03-19 |
| Recall number | D-0528-2023 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Durham NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.