The Recall Desk
SevereFDA (Drugs)·D-1100-2015·Announced 2015-06-03

Advanced Physician Solutions Recalls Hydroxyzine Hydrochloride Injectable Due to Sterility Concerns

Advanced Physician Solutions is recalling Hydroxyzine Hydrochloride Injectable vials because the FDA identified 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Advanced Physician Solutions, Inc. is recalling Hydroxyzine Hydrochloride (Sterile Water) 25mg/mL Injectable vials. The recall was initiated due to a lack of assurance of sterility in the product.

The affected product is a 10mL vial containing 25mg/mL of Hydroxyzine Hydrochloride in sterile water. The recall covers all lots of this specific product. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Affected units
2

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 →