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U.S. Department of Health and Human Services

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