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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25
Recall Number D-1421-2012
Classification Class II
Code Info Lot #1395 Exp: July 2012
Product Distributed Qty 63,750 ampules
Reason For Recall Presence of Particulate Matter

Event Detail

Event Id 61714
Product Type Drugs
Status Ongoing
Recalling Firm Luitpold Pharmaceuticals, Inc.
City Shirley
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide