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U.S. Department of Health and Human Services

Enforcement Report - Week of March 13, 2013

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Product Detail

Product Description Thrombin, Topical (Human) Evithrom Rx only Distributor: Johnson & Johnson Wound Management A division of Ethicon, Inc. Manufacturer: Omrix Biopharmaceuticals Ltd. 2 mL - NDC 63713-460-02 5 mL- NDC 63713-460-05
Recall Number B-1049-13
Classification Class III
Code Info Evithrom 2mL Product Code S4602, Lot Number Q36T62K; Product Code 4602, Lot Numbers P49T05K, Q11T44J, Q2T46K, Q45T77J; Evithrom 5 mL Product Code 4605 Lot Numbers P46T84J, P50T150, Q07T23J, Q08T28K, Q23T88K, Q25T93J, Q25T94J, Q27T08J, Q30T31J, Q31T34J, Q31T360, Q32T41K, Q33T48J
Product Distributed Qty 18
Reason For Recall Evicel and Evithrom, manufactured with a processing deviation that potentially led to decreased potency, were distributed.

Event Detail

Event Id 63282
Product Type Biologics
Status Ongoing
Recalling Firm Ethicon, Inc.
City Somerville
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Foreign (Canada, Israel, Singapore, and Switzerland)