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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 65017
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 2013-03-11
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1. Lot #: 610593, Exp 06/13 Class III Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. 11,472 bottles D-302-2013