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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
Recall Number D-1325-2014
Classification Class II
Code Info 34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15
Product Distributed Qty 53,452 bottles
Reason For Recall Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

Event Detail

Event Id 68069
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City North Wales
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico