Axium Healthcare Recalls Cyclosporin Injectable Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling all lots of Cyclosporin in Corn Oil Injectable due to 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. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable products are categorized as Severe (Score 4), particularly when specific injury reports are not explicitly detailed but the hazard is significant.
Plain-English summary
Axium Healthcare Pharmacy dba Balanced Solutions Compounding is recalling all lots of Cyclosporin in Corn Oil Injectable, 1 vial (15 mL). The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy, along with concerns regarding quality control processes.
The affected product was distributed in Colorado, Georgia, Michigan, and Puerto Rico. The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Cyclosporin in Corn Oil 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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