Product Detail

Product Description HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

Recall Number D-603-2013

Classification Class III

Code Info Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)

Product Distributed Qty lot 608917: 7764 bottles; lot 608204: 7476 bottles

Reason For Recall Subpotent; 24 month stability test station

Event Detail

Event Id 65047

Product Type Drugs

Status Ongoing

Recalling Firm
Hi-Tech Pharmacal Co., Inc.
City Amityville

State NY
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-30

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide and Puerto Rico