FDA Drug Recalls

Recalls / Class II

Class IID-1314-2019

Product

INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.

Affected lot / code info
Batch #: 7304, 7180, 6707, 7065

Why it was recalled

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

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
17,850 pounds per batch
Distribution pattern
Nationwide in the USA

Timeline

Recall initiated
2019-04-22
FDA classified
2019-05-29
Posted by FDA
2019-06-05
Terminated
2024-08-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1314-2019. 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