Recall Record

Niles, IL, United States

Alva-Amco Pharmacal Companies., Inc. recalls

1 recall recorded since 2018, most recently on 9 March 2018. 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 III Drugs

Recall started
9 March 2018
Terminated
26 June 2020
Reason
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Distribution
Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria
Initiated
Voluntary: Firm initiated
Recall number
D-0589-2018

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.