Axium Healthcare Recalls Cyanocobalamin Injectables Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Cyanocobalamin (CMP) Injectable vials due to a lack of assurance of sterility and quality control concerns.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling Cyanocobalamin (CMP) Injectable vials. The recall involves 15 vials (30 mL each) distributed to Colorado, Georgia, Michigan, and Puerto Rico. The recall covers all lots of the product.
The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the pharmacy's quality control processes as the reason for the action.
Consumers who have purchased or received these vials should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 26 recalled by Axium Healthcare Pharmacy dba Balanced Solutions Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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