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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Product Detail

Product Description Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.
Recall Number D-1426-2012
Classification Class III
Code Info Lot #: 418N, Exp 06/13
Product Distributed Qty 444 bottles
Reason For Recall Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.

Event Detail

Event Id 62136
Product Type Drugs
Status Ongoing
Recalling Firm Fougera Pharmaceuticals, Inc.
City Hicksville
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.