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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 Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
Recall Number D-1422-2012
Classification Class III
Code Info Lot #: : PUB1040, Exp 08/2015
Product Distributed Qty 4,848 bottles
Reason For Recall Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.

Event Detail

Event Id 51880
Product Type Drugs
Status Terminated
Recalling Firm Pack Pharmaceuticals
City Buffalo Grove
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide