Recall Record

Mainland, PA, United States

Accupac, Inc. recalls

1 recall recorded since 2018, most recently on 13 May 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)0

Terminated Class II Drugs

Recall started
13 May 2021
Terminated
11 August 2021
Reason
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Distribution
Naitonwide in the US and Puerto Rico.
Initiated
Voluntary: Firm initiated
Recall number
D-0598-2021

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.