FDA Drug Recalls

Recalls / Class II

Class IID-140-2013

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

Brand name
Hillyard Alcohol Free Foaming Instant Hand Sanitizer
Generic name
Benzalkonium Chloride
Active ingredient
Benzalkonium Chloride
Route
Topical
NDC
76402-403
FDA application
505G(a)(3)
Affected lot / code info
Lot 1025554, Exp: 03/14 and Lot 1030652, Exp: 09/14

Why it was recalled

Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.

Recalling firm

Firm
Hillyard GMP
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
421 N 2nd St, Saint Joseph, Missouri 64504

Distribution

Quantity
2,139 bottles
Distribution pattern
Distribution nationwide

Timeline

Recall initiated
2012-12-28
FDA classified
2013-01-31
Posted by FDA
2013-02-06
Terminated
2014-01-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-140-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: Hillyard Alcohol Free Foaming Instant Hand Sanitizer · FDA Drug Recalls