Axium Healthcare Recalls Comprehensive Injection #4 Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Comprehensive Injection #4 because the compounding process lacked assurance of sterility. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
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, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the lack of sterility assurance in injectable products poses a significant risk of serious adverse health consequences, fitting the Severe category for Class II drug recalls with potential for hospitalization.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling Comprehensive Injection #4 - SS varied injectable. The recall involves 10 vials (30 mL each) of the injectable product. The company is recalling all lots of this product due to a lack of assurance of sterility and concerns regarding quality control processes.
The affected product was distributed in Colorado, Georgia, Michigan, and Puerto Rico. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is driven by the inability to guarantee that the compounded sterile products were free from microbial contamination.
The recalled product
- Product
- Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Category
- Drug — Compounded 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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