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.
Recall initiated: 20230329
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated