Enforcement Report - Week of October 17, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | B-2498-12 |
| Classification | Class II |
| Code Info | Lot Number: 200795 |
| Product Distributed Qty | 1 Lot |
| Reason For Recall | Mislabeled vials of Allergenic Extract were distributed. |
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 |
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