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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
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