Axium Healthcare Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling all lots of Bacteriostatic Water for Injection 0.9% 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Axium Healthcare Pharmacy dba Balanced Solutions Compounding is recalling all lots of Bacteriostatic Water for Injection 0.9%. The recall was initiated 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 affected product was distributed to Colorado, Georgia, Michigan, and Puerto Rico. The recall covers all lots of the product.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Bacteriostatic Water for Injection 0.9% 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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