DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega
Summary
The FDA issued a Class II for DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) by Omega & Delta Co., Inc.. Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed di.
Details
Source
Drug Recall
External ID
D-0104-2024
Action Date
2023-11-22
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #s 1113005, 1116005, 0237088, 0232084, 012764, 012864, 0244096, 0245096.
Quantity Affected: 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.
Distribution
Distributed in Puerto Rico only.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
Carolina, PR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Omega & Delta Co., Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Omega & Delta Co., Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Omega & Delta Co., Inc. have FDA actions?
Omega & Delta Co., Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0104-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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