PlainRecalls
FDA Drug Moderate Class II Terminated

Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566

Reported: June 5, 2019 Initiated: April 22, 2019 #D-1315-2019

Product Description

Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566

Reason for Recall

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

Details

Recalling Firm
Inopak Ltd
Units Affected
17,850 pounds per batch
Distribution
Nationwide in the USA
Location
Ringwood, NJ

Frequently Asked Questions

What product was recalled?
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with Chlorhexidine Gluconate; 1000ML pouches, 8/1000ML pouches per case, Walter G. Legge Co Inc, 444 Central AVE, Peekskill, NY 10566. Recalled by Inopak Ltd. Units affected: 17,850 pounds per batch.
Why was this product recalled?
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 5, 2019. Severity: Moderate. Recall number: D-1315-2019.