December 2012 FDA Recall Hillyard Alcohol Free Foaming Instant Hand Sanitizer by Hillyard Gmp
D-140-2013 - Microbial Contamination of Non-Sterile Products
This Class II drug recall was voluntarily initiated by Hillyard Gmp on December 28, 2012 for the product Hillyard Alcohol Free Foaming Instant Hand Sanitizer. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-140-2013
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
12-28-2012
02-06-2013
2,139 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hillyard GMP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distribution nationwide
01-29-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
Batch or Lot Expiration Information
Lot# Lot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14