Axium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is lacking is categorized as Severe (Score 4), as it poses a significant risk of infection or other adverse health consequences.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling Triamcinolone Hexacetonide Injectable. The affected product consists of 28 vials, each containing 10 mL of the injectable solution. The recall is being conducted because of a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy, along with concerns regarding their quality control processes.
The recall covers all lots of the product. The affected vials were distributed to Colorado, Georgia, Michigan, and Puerto Rico. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers who have purchased or received this product should stop using it and contact Axium Healthcare Pharmacy or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
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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