The Recall Desk
SevereFDA (Drugs)·D-1093-2015·Announced 2015-06-03

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.

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 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
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.

See all 18 products in this recall →