PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 13, 2015 Initiated: March 31, 2015 #D-0992-2015

Product Description

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

Details

Recalling Firm
Cody Laboratories, Inc.
Units Affected
19,139 bottles
Distribution
Nationwide
Location
Cody, WY

Frequently Asked Questions

What product 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. Recalled by Cody Laboratories, Inc.. Units affected: 19,139 bottles.
Why was this product recalled?
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Which agency issued this recall?
This recall was issued by the FDA Drug on May 13, 2015. Severity: Moderate. Recall number: D-0992-2015.