FDA recall D-0589-2018

Product

Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.

Reason for recall

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

Key facts

Status

Terminated

Initiation date

2018-03-09

Report date

2018-03-21

Termination date

2020-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Niles, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0589-2018