March 2018 FDA Recall Drug by Alva-amco Pharmacal Companies., Inc.
D-0589-2018 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Alva-amco Pharmacal Companies., Inc. on March 9, 2018 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0589-2018

Reason for Recall
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Initiated
03-09-2018
Reported
03-21-2018
Quantity
206,513 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79450
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Alva-Amco Pharmacal Companies., Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA; Italy; Sweden; Germany; New Zealand; Netherlands; Australia; Moldova; United Kingdom; Mexico; Brazil; Chile; Greece; Spain; Norway; Belgium; Bulgaria
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-26-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration 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