Drug product

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

D-0105-2024

October 20, 2023

Class II

Product summary

Firm: Omega & Delta Co., Inc.
Event: Event 93159
Status: Ongoing
Classification: Class II
Quantity: 4,848 7.5 oz bottles
Official record key: drug-enforcement:D-0105-2024

Official wording

Reason: 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.

Code information: Lot #s 006511

Distribution pattern: Distributed in Puerto Rico only.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.