March 2012 FDA Recall Drug by Quadrant Chemical Corporation (D-1380-2012 - Subpotent (Single Ingredient Drug))

This Class III drug recall was voluntarily initiated by Quadrant Chemical Corporation on March 20, 2012 for the product Drug. The FDA reported the reason for recall as subpotent (single ingredient drug). The product was distributed in Maine and the recall is currently terminated.

Recall Number: D-1380-2012

Reason for Recall
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Initiated
03-20-2012
Reported
06-20-2012
Quantity
4800 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61518
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.
Quadrant Chemical Corporation
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Maine
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-13-2012
Product Description About Product Description
Full technical description of the product.
DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070

Batch or Lot Expiration Information

Lot# Lot 022110-01