October 2018 FDA Recall Hydroxyzine Hydrochloride by Lannett Company, Inc.
D-0083-2019 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Lannett Company, Inc. on October 11, 2018 for the product Hydroxyzine Hydrochloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0083-2019
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
10-11-2018
10-31-2018
8,324 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lannett Company, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
02-22-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
