FDA recall D-0105-2024

Omega & Delta Co., Inc. · Class II · drug

Product

Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

Reason for recall

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Distribution

Distributed in Puerto Rico only.

Key facts

Status
Ongoing
Initiation date
2023-10-20
Report date
2023-11-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carolina, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0105-2024