Axium Healthcare Recalls DMSO Bladder Irrigation Solution Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling DMSO 50% Sterile Bladder Irrigation Solution because the company cannot ensure the product is sterile.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a risk of harm (sterility failure) where injury has not yet been reported falls under the 'Severe' category (Score 4), as it is not a Class I (Critical) but involves significant quality control failures.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling DMSO 50% Sterile Bladder Irrigation Solution. The recall involves 2 50 mL vials of the product. The company states that the recall is necessary because it lacks assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. This decision is based on concerns associated with the pharmacy's quality control processes.
The affected product was distributed to Colorado, Georgia, Michigan, and Puerto Rico. The recall covers all lots of the product. The FDA has classified this recall as Class II, which means there is a reasonable probability that the 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 instructions on how to return or dispose of the medication.
The recalled product
- Product
- DMSO 50% Sterile Bladder Irrigation Solution 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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