The Recall Desk
SevereFDA (Drugs)·D-1094-2015·Announced 2015-06-03

Advanced Physician Solutions Recalls Estradiol Valerate Injectable Due to Sterility Concerns

Advanced Physician Solutions is recalling 17 vials of Estradiol Valerate Injectable 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when the hazard involves a lack of assurance of sterility in an injectable product.

Plain-English summary

Advanced Physician Solutions, Inc. is recalling 17 vials of Estradiol Valerate (10ml Vial) Sesame Oil 45mg/ml Injectable. The product was distributed nationwide by Advanced Compounding Pharmacy in North Hollywood, California. The recall covers all lots of the product.

The recall was initiated due to a lack of assurance of sterility. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Affected units
17

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 →