Phosphatidylcholine Injectable Recalled for Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling Phosphatidylcholine Injectable due to lack of sterility assurance and quality control concerns.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score 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 Phosphatidylcholine Injectable. The recall involves 5 vials (3 mL each) of the product. The recall is being conducted because of a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy, as well as concerns associated with the quality control processes.
The affected product was distributed to Colorado, Georgia, Michigan, and Puerto Rico. All lots of the product are included in this recall.
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
- Phosphatidylcholine 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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