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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30 Lot: DL11600 Exp Date: 06/13 Class III Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength. 81,516 bottles D-1683-2012