RecallDepth
Class II Terminated

BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.

Company
Teva Pharmaceuticals Usa
Recall Initiated
April 7, 2014
Posted
May 28, 2014
Recall Number
D-1324-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
17,181 bottles
Firm Location
North Wales, PA, United States

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot #: 34013132A, 34013133A, 34013134A, 34013135A, 34013136A, Exp 11/14

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