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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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Product Detail

Product Description Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Recall Number D-104-2013
Classification Class II
Code Info 11T7011A, Exp. Date: 12/2012
Product Distributed Qty 7,432 bottles
Reason For Recall Subpotent; 15 month stability

Event Detail

Event Id 63608
Product Type Drugs
Status Ongoing
Recalling Firm Alara Pharmaceutical Co
City San Juan
State PR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide