Axium Healthcare Recalls Sodium Tetradecyl Sulfate Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate for 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 severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Axium Healthcare Pharmacy dba Balanced Solutions Compounding is recalling Sodium Tetradecyl Sulfate for Injectable. The product consists of 5 vials (30 mL each) and was distributed in Colorado, Georgia, Michigan, and Puerto Rico. The recall covers all lots of the product.
The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the quality control processes as the reason for the action.
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
- Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Category
- Drug — Compounded 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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