Hydroxyzine Hydrochloride Solution
FDA Recall NDC 54838-502
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hydroxyzine Hydrochloride (NDC 54838-502). A significant event, classified as Class II, was initiated on Oct 11, 2018 by Lannett Company, Inc.. The reported reason for this action was: "CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Oct 11, 2018
Oct 31, 2018
8,324 bottles
Recall Profile & Regulatory Data
Event ID
81225
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lannett Company, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Feb 22, 2019
Product Description
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
Batch or Lot Expiration Information
Lot# : 1097, Exp 10/18
Affected Packages Involved in this Recall
54838-502-80Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
