Drug & medication recalls Moderate risk

Cody Laboratories, Inc. recalls C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for…

Recall date
March 31, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0992-2015
FDA classification
Class II
Brand / firm
Cody Laboratories, Inc.
Sold / distributed
Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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