FDA recall D-1315-2019

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-22

Report date

2019-06-05

Termination date

2024-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ringwood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1315-2019