FDA recall D-1285-2014

Genesis Pharmaceutical, Inc. · Class III · drug

Product

Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2

Reason for recall

Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-04-01
Report date: 2014-05-07
Termination date: 2014-10-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Henderson, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1285-2014