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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description Hepatitis B Vaccine (Recombinant)
Recall Number B-0625-14
Classification Class II
Code Info J001183
Product Distributed Qty 1 Lot
Reason For Recall Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed.

Event Detail

Event Id 68127
Product Type Biologics
Status Completed
Recalling Firm Merck Sharpe & Dohme Corp
City West Point
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Multiple U.S. States