Enforcement Report - Week of September 26, 2012
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Product Detail
| Product Description | Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 |
|---|---|
| Recall Number | D-1683-2012 |
| Classification | Class III |
| Code Info | Lot: DL11600 Exp Date: 06/13 |
| Product Distributed Qty | 81,516 bottles |
| Reason For Recall | Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. |
Event Detail
| Event Id | 63080 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Apace KY LLC |
| City | Fountain Run |
| State | KY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-04 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide |
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