Drug Enforcement D-0104-2024

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.

Status

Ongoing

Classification

Class II

Report Date

November 22, 2023

Termination Date

Product Information

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
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.
Recall initiation reason
Initial firm notification
E-Mail
Distribution pattern
Distributed in Puerto Rico only.

Location & Firm

Recalling firm
Omega & Delta Co., Inc.
Address
Carr. 887 Km 0 Hm 8 Julio N. Matos Ind. Park Bldg#10, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0104-2024
Event ID
93159
Recall initiation date
October 20, 2023
Center classification date
November 14, 2023
Code info
Lot #s 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, 0245096.
More code info