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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description 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.
Recall Number D-302-2013
Classification Class III
Code Info Lot #: 610593, Exp 06/13
Product Distributed Qty 11,472 bottles
Reason For Recall Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

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 Letter
Distribution Pattern Nationwide and Puerto Rico