FDA-Drug2023-11-22Class II

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4

Omega & Delta Co., Inc.
Hazard

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.

Sold states
Distributed in Puerto Rico only.
Affected count
48,145 4 oz bottles
Manufactured in
Carr. 887 Km 0 Hm 8 Julio N. Matos Ind. Park Bldg#10, N/A, Carolina, PR, United States
Products
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0103-2024

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