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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Event Detail

Event ID 62921
Product Type Biologics
Status Ongoing
Recalling Firm Greer Laboratories Inc
City Lenoir
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern CA, IL, IA, NM, TN

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Product is a 50% glycerinated Aspergillus niger (Human) Allergenic Extract in liquid form. Product is vialed in 10 mL type 1 glass vials,stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap. Lot Number: 200795 Class II Mislabeled vials of Allergenic Extract were distributed. 1 Lot B-2498-12
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