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 Id 65017

Product Type Drugs

Status Ongoing

Recalling Firm Hi-Tech Pharmacal Co., Inc., Amityville, NY, USA

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