Home / Recalls / Alva-Amco Pharmacal Companies., Inc. / D-0589-2018

D-0589-2018 Class III Terminated

Recalled by Alva-Amco Pharmacal Companies., Inc. — Niles, IL

Recall Details

Product Type: Drugs
Report Date: March 21, 2018
Initiation Date: March 9, 2018
Termination Date: June 26, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 206,513 tubes

Product Description

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 Pattern

Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria

Code Information

Lot #: 61031, 61041, 61051, Exp. 4/30/2018; 61601, 61651, 61751, Exp. 6/30/2018; 61941, Exp. 7/31/2018; 62321, Exp. 8/31/2018; 62561, 62721, Exp. 9/30/2018; 62871, Exp. 10/31/2018; 63331, Exp. 11/30/2018; 72011, 72021, 72131, 72141, Exp. 7/31/2019; 72221, 72441, Exp. 8/31/2019; 72921, Exp. 10/31/2019; 73351, Exp. 11/30/2019