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

FDA recall notice · announced May 13, 2015 · Cody Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot 14834012, Exp 01/2016
Quantity: 19,139 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0992-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.