FDA recall D-0102-2021

Product

SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .

Reason for recall

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

Distribution

Texas

Key facts

Status

Completed

Initiation date

2020-09-24

Report date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Laredo, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2021