FDA recall D-1555-2020

Product

Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged in a) 16.9 Fl. Oz. (1.06 pint, 500 mL), NDC# 65055-600-02, UPC# 759684515033, b) 4 Fl. Oz.(120 mL), NDC# 65055-600-01, UPC# 75968455026, Laboratorios Jaloma S.A. DE C.V., Aquiles Serdan 438, Z.P. 44380, Guadalajara, Jalisco, Mexico, Made in Mexico.

Reason for recall

cGMP deviations

Distribution

Nationwide United States and Canada.

Key facts

Status

Terminated

Initiation date

2020-07-31

Report date

2020-09-09

Termination date

2022-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guadalajara, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1555-2020