HCG Lyophilized Powder Recalled for Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
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 an injectable product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling HCG Lyophilized Powder 10,000 unit for Injectable. The recall is being conducted because the product lacks sterility assurance. The affected product is a 10 mL vial of lyophilized powder intended for injection.
The recall covers all lots of the product. It was distributed in Colorado, Georgia, Michigan, and Puerto Rico. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. No specific dates or lot numbers beyond 'ALL Lots' are provided in the source text.
The recalled product
- Product
- HCG Lyophylized Powder 10,000 unit for 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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