FDA-Drug2015-05-13Class II

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

Cody Laboratories, Inc.
Hazard

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

Sold states
Nationwide
Affected count
19,139 bottles
Manufactured in
601 Yellowstone Ave, N/A, Cody, WY, United States
Products
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

Official notice

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

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