September 2012 FDA Recall Drug by Apace Ky Llc
D-1683-2012 - Labeling Illegible

This Class III drug recall was voluntarily initiated by Apace Ky Llc on September 4, 2012 for the product Drug. The FDA reported the reason for recall as labeling illegible. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1683-2012

Reason for Recall
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
Initiated
09-04-2012
Reported
09-26-2012
Quantity
81,516 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63080
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Apace KY LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-10-2013
Product Description About Product Description
Full technical description of the product.
Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

Batch or Lot Expiration Information

Lot# Lot: DL11600 Exp Date: 06/13