FDA recall D-0992-2015

Cody Laboratories, Inc. · Class II · drug

Product

C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414

Reason for recall

Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-03-31
Report date: 2015-05-13
Termination date: 2015-10-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cody, WY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0992-2015