FDA recall D-0647-2021

DIBAR NUTRICIONAL S DE RL DE CV · Class II · drug

Product

ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1

Reason for recall

CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-05-11
Report date
2021-07-07
Termination date
2023-03-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morelia, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2021