Axium Healthcare Recalls 17 Alpha Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable vials 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 source text identifies a lack of sterility assurance in an injectable drug, which poses a risk of serious infection. Per the rubric, FDA Class II recalls involving significant injury risks or structural defects in medical products are classified as Severe.
Plain-English summary
Axium Healthcare Pharmacy, doing business as Balanced Solutions Compounding, is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable. The product consists of 4 vials (5 mL each) and was distributed to 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 identified concerns associated with the pharmacy's quality control processes that compromise the sterility of the injectable medication.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 17 Alpha Hydroxyprogesterone Caproate 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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