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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
Recall Number D-1356-2014
Classification Class II
Code Info Lot # A358502; Exp 01/15
Product Distributed Qty 4,155 bottles
Reason For Recall Defective Container: Tamper evident ring failures discovered on some bottles.

Event Detail

Event Id 67532
Product Type Drugs
Status Ongoing
Recalling Firm Pfizer Inc.
City New York
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Italy and Republic of South Korea