Advanced Compounding Pharmacy Recalls Hydroxyzine Hydrochloride Injectable Due to Sterility Concerns
Advanced Physician Solutions, Inc. is recalling Hydroxyzine Hydrochloride Injectable because the product lacks assurance of sterility. The recall covers 3 vials distributed nationwide.
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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product warrants a score of 4 (Severe).
Plain-English summary
Advanced Physician Solutions, Inc. is recalling Hydroxyzine Hydrochloride (30ml Vial) (Sterile Water) 50mg/ml Injectable. The recall is being conducted because the product lacks assurance of sterility.
The recalled product consists of 3 vials. 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 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
- HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
- Manufacturer
- Advanced Physician Solutions, Inc.
- Category
- Drug — Injectable
- Affected units
- 3
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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