Recall Record

Farmingdale, NY, United States

Valisa MFG LLC recalls

1 recall recorded since 2018, most recently on 6 December 2021. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1

Terminated Class I Drugs

Recall started
6 December 2021
Terminated
26 February 2024
Reason
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0363-2022

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.