Accord Healthcare, Inc. is recalling 4,574 cartons of Dodex (cyanocobalamin) Injectable Injection, USP 1,000 mcg/mL. Testing conducted at the nine-month mark revealed that the medication is sub-potent, meaning it does not contain the full strength of Vitamin B12 specified on the label. The recalled products consist of cartons containing 25 x 1 mL multiple-dose vials and were distributed nationwide to pharmacies and healthcare providers.
A sub-potent Vitamin B12 injection may not provide the intended therapeutic dose, which could lead to ineffective treatment of Vitamin B12 deficiency and associated conditions like anemia. No injuries or incidents related to this issue have been reported to date.
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Manufactured by Intas Pharmaceuticals Limited; Manufactured for Accord Healthcare, Inc.
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Sources: FDA iRES · Raw API Response
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