FDA Drug Recalls

Recalls / Class II

Class IID-1306-2014

Product

Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

Affected lot / code info
Lot Code: 13350

Why it was recalled

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

Recalling firm

Firm
Mangiacotti
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
117 Pleasant Street, N/A, Attleboro, Massachusetts 02703

Distribution

Quantity
N/A
Distribution pattern
Nationwide

Timeline

Recall initiated
2013-12-27
FDA classified
2014-05-06
Posted by FDA
2014-05-14
Terminated
2016-04-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1306-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls