Recalls / Class III
Class IIID-0528-2023
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.
- Affected lot / code info
- Lot #: R2200394 Exp. 03/2024
Why it was recalled
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 4574 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-03-29
- FDA classified
- 2023-04-06
- Posted by FDA
- 2023-04-12
- Terminated
- 2025-03-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0528-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.