Betamethasone Injectable Recalled Due to Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling Betamethasone Injectable 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. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility assurance in injectable products corresponds to a 'Severe' severity score.
Plain-English summary
Axium Healthcare Pharmacy dba Balanced Solutions Compounding is recalling Betamethasone Injectable. The recall involves 401 vials (10 mL vials each) distributed to Colorado, Georgia, Michigan, and Puerto Rico.
The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The agency cited concerns associated with the quality control processes.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm for further instructions.
The recalled product
- Product
- Betamethasone 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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