Aurobindo Pharma USA Inc. is recalling 433,809 vials of Auromedics Cyanocobalamin (Vitamin B12) Injection, USP. The medication is being recalled because testing showed it was subpotent, meaning it may not contain the full amount of active ingredient required by quality standards. This prescription drug is used for intramuscular or subcutaneous injection and was distributed nationwide in 1 mL vials.
Because the drug is subpotent, patients may receive less than the intended dose of vitamin B12, which can lead to ineffective treatment of vitamin deficiencies. No incidents or injuries have been reported to date.
Manufactured in India for Auromedics Pharma LLC.
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Sources: FDA iRES · Raw API Response
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