FDA Recalls Quadmix Custom Injectable Due to Sterility Assurance Concerns
Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance 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 with potential for hospitalization or significant injury are rated as Severe (4). Lack of sterility assurance in injectable products poses a risk of serious infection.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling all lots of Quadmix Custom Injectable Balanced Solutions. The recall is being conducted because the compounding pharmacy lacked assurance of sterility for the products it compounded, repackaged, and distributed. The recall is also driven by concerns associated with the pharmacy's quality control processes.
The affected product consists of 3 vials (10 mL vials) of Quadmix Custom Injectable. The recall covers all lots of this product. The products were distributed in Colorado, Georgia, Michigan, and Puerto Rico.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. 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.
The recalled product
- Product
- Quadmix Custom 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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