BiMix Standard Injectable Recalled for Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling BiMix Standard 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. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable products are categorized as Severe.
Plain-English summary
Axium Healthcare Pharmacy dba Balanced Solutions Compounding is recalling BiMix Standard Injectable. The recall is being conducted because of a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The decision is based on concerns associated with the facility's quality control processes.
The recall affects all lots of the product. The affected products were distributed to Colorado, Georgia, Michigan, and Puerto Rico.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- BiMix Standard 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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