Advanced Physician Solutions Recalls Estradiol Cypionate Injectable Due to Sterility Concerns
Advanced Physician Solutions, Inc. is recalling Estradiol Cypionate injectable vials because the FDA determined there is a lack of assurance of sterility.
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 hospitalization if contaminated.
Plain-English summary
Advanced Physician Solutions, Inc. is recalling Estradiol Cypionate (Sesame Oil) 10ml and 30ml vials (5mg/ml) manufactured by Advanced Compounding Pharmacy in North Hollywood, California. The recall was initiated due to a lack of assurance of sterility in the product.
The recall involves 21 vials distributed nationwide. The source text does not specify particular lot numbers, stating that all lots are affected. No specific dates of distribution or illness reports are provided in the notice.
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
- ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
- Manufacturer
- Advanced Physician Solutions, Inc.
- Category
- Drug — Injectable
- Affected units
- 21
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.
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