Axium Healthcare Recalls Mono-mix Injectable Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Mono-mix (Prostaglandin) 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from non-sterile injectable products.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling Mono-mix (Prostaglandin) Injectable. The recall involves 15 vials (10 mL each) of the product. The recall was initiated because of a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy, as well as concerns associated with its quality control processes.
The affected product was distributed in Colorado, Georgia, Michigan, and Puerto Rico. The recall covers all lots of the product. No specific dates or additional distribution details are provided in the source text.
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
- Mono-mix (Prostaglandin) 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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