Omega & Delta Co., Inc.: Drug Recall

Recall #D-0104-2024 · 10/20/2023

Class II: Risk

Recall Details

Recall Number
D-0104-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Omega & Delta Co., Inc.
Status
Ongoing
Date Initiated
10/20/2023
Location
Carolina, PR, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,136 8 OZ bottles

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.

Product Description

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4

Distribution Pattern

Distributed in Puerto Rico only.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.