August 2014 FDA Recall Drug by Hli Dba Humphreyline Inc
D-1518-2014 - Microbial Contamination of Non-Sterile Product

This Class II drug recall was voluntarily initiated by Hli Dba Humphreyline Inc on August 6, 2014 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed in Kentucky, Maryland, and Virginia. and the recall is currently terminated.

Recall Number: D-1518-2014

Reason for Recall
Microbial Contamination of Non-Sterile Product
Initiated
08-06-2014
Reported
08-13-2014
Quantity
975 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68950
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
HLI dba Humphreyline Inc
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Kentucky, Maryland, and Virginia.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2014
Product Description About Product Description
Full technical description of the product.
Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing.

Batch or Lot Expiration Information

Lot# : MB140417; Expiry: 04/2017.