Recall Record

Hillsborough, NC, United States

Phe Inc recalls

1 recall recorded since 2018, most recently on 18 August 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

Completed Class I Drugs

Recall started
18 August 2021
Reason
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Distribution
Nationwide within the United States
Initiated
Voluntary: Firm initiated
Recall number
D-0819-2021

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.