PlainRecalls
FDA Drug Moderate Class II Terminated

Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02

Reported: October 11, 2017 Initiated: August 23, 2017 #D-0002-2018

Product Description

Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02

Reason for Recall

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

Details

Recalling Firm
Inopak Ltd
Units Affected
N/A
Distribution
nationwide
Location
Ringwood, NJ

Frequently Asked Questions

What product was recalled?
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02. Recalled by Inopak Ltd. Units affected: N/A.
Why was this product recalled?
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Which agency issued this recall?
This recall was issued by the FDA Drug on October 11, 2017. Severity: Moderate. Recall number: D-0002-2018.