Recall Record

Carolina, PR, United States

Omega & Delta Co., Inc. recalls

1 recall recorded since 2018, most recently on 20 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Drugs

Recall started
20 October 2023
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.
Distribution
Distributed in Puerto Rico only.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0105-2024, D-0104-2024, D-0103-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.