Methylprednisolone Acetate Injectable Recalled for Sterility Assurance Concerns
Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate 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 and involves a lack of sterility assurance in injectable products, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling Methylprednisolone Acetate injectable vials. The recall involves 326 vials (10 mL each) distributed to Colorado, Georgia, Michigan, and Puerto Rico.
The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The agency cited concerns associated with the pharmacy's quality control processes.
Consumers and healthcare providers who have received these products should stop using them and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Methylprednisolone Acetate 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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