Advanced Physician Solutions Recalls Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns
Advanced Physician Solutions is recalling Hydroxyprogesterone Caproate injectable vials because the company cannot ensure the product is sterile.
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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Advanced Physician Solutions, Inc. is recalling Hydroxyprogesterone Caproate (Olive Oil) 30ml, 10ml vial 250mg/ml injectable products. The recall was initiated because the company lacks assurance of the sterility of the product.
The recalled product is a 250mg/ml injectable solution in 10ml vials, with a total quantity of 28 vials involved. The distribution pattern is nationwide, and the recall applies to all lots. The product was manufactured by Advanced Compounding Pharmacy located in North Hollywood, California.
Consumers and healthcare providers 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. No specific dates or lot numbers are provided in the source text.
The recalled product
- Product
- HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
- Manufacturer
- Advanced Physician Solutions, Inc.
- Category
- Drug — Injectable
- Affected units
- 28
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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Advanced Physician Solutions, Inc. 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.
See all 18 products in this recall →Related recalls
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