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
D-0992-2015
Product summary
- Event
- Event 70921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,139 bottles
- Official record key
drug-enforcement:D-0992-2015
Official wording
Reason: Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Code information: Lot 14834012, Exp 01/2016
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up