Drug Enforcement D-1683-2012

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

Status

Terminated

Classification

Class III

Report Date

September 26, 2012

Termination Date

July 10, 2013

Product Information

Product description
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Product quantity
81,516 bottles
Reason for recall
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Apace KY LLC
Address
12954 Fountain Run Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-1683-2012
Event ID
63080
Recall initiation date
September 4, 2012
Center classification date
September 19, 2012
Code info
Lot: DL11600 Exp Date: 06/13
More code info