Recall Record

Denver, CO, United States

Optikem International, Inc. recalls

1 recall recorded since 2018, most recently on 29 February 2024. 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
29 February 2024
Reason
Lack of Assurance of Sterility
Distribution
Product distributed Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-0380-2024, D-0375-2024, D-0381-2024, D-0379-2024, D-0383-2024, D-0377-2024, D-0376-2024, D-0382-2024, D-0378-2024, D-0384-2024

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.