Progesterone Injectable Recalled Due to Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling all lots of Progesterone in Olive Oil Injectable due to lack of sterility assurance and quality control concerns.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 rating under the rubric, particularly given the risk of infection from non-sterile injectable products.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling all lots of Progesterone in Olive Oil Injectable. The product consists of 11 vials (10 mL each) and was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
The recall was initiated because the compounding pharmacy lacked assurance of sterility for all sterile products compounded, repackaged, and distributed by the facility. The agency cited concerns associated with the pharmacy's 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 further instructions. The recall covers all lots of the specific product identified in the notice.
The recalled product
- Product
- Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium 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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