FDA recall D-1559-2020

ROQUE PLAST, S.A. DE C.V. · Class II · drug

Product

Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250mL bottle, Roqueplast S.A. de C.V. Cda. Adolfo Manfredi #7 Altizapan de Zaragoza CP 52958 Edo de Mexico UPC 8 52239 00689 2

Reason for recall

CGMP Deviation: Potential contamination with undeclared methanol.

Distribution

Distributed Nationwide in the US

Key facts

Status: Terminated
Initiation date: 2020-08-04
Report date: 2020-09-09
Termination date: 2022-02-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Atizapan De Zaragoza, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1559-2020