FDA Drug Recalls

Recalls / Class II

Class IID-0004-2018

Product

Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ

Affected lot / code info
All lots within expiry

Why it was recalled

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

Recalling firm

Firm
Inopak Ltd
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
24 Executive Pkwy, N/A, Ringwood, New Jersey 07456-1430

Distribution

Quantity
N/A
Distribution pattern
nationwide

Timeline

Recall initiated
2017-08-23
FDA classified
2017-10-04
Posted by FDA
2017-10-11
Terminated
2020-04-20
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0004-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.