FDA recall D-1380-2012

Quadrant Chemical Corporation · Class III · drug

Product

DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070

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.

Distribution

Maine

Key facts

Status: Terminated
Initiation date: 2012-03-20
Report date: 2012-06-20
Termination date: 2012-09-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Garland, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1380-2012