FDA Recalls Methylcobalamin and Folic Acid Injectables Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Methylcobalamin and Folic Acid Injectables because the products may lack sterility assurance.
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. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in injectables) corresponds to a severity score of 4 (Severe).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Methylcobalamin and Folic Acid Injectable products manufactured by Axium Healthcare Pharmacy dba Balanced Solutions Compounding. The recall involves 29 vials (9 mL and 30 mL) distributed to Colorado, Georgia, Michigan, and Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. The FDA cited concerns associated with the quality control processes used to compound, repackage, and distribute these sterile products. Because the sterility of the injectables cannot be guaranteed, there is a potential risk of contamination.
Consumers and healthcare providers who have these products should stop using them immediately. They should contact their healthcare provider for guidance on alternative treatments or further instructions. The recall covers all lots of the affected product.
The recalled product
- Product
- Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Category
- Drug — Injectable
- Hazard
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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