FDA Drug recall D-0992-2015
C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc
- FDA Drug
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc by Cody Laboratories, citing labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0992-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-31 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Cody Laboratories |
| Distribution | US |
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
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Identifiers
| code_info | Lot 14834012, Exp 01/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0992-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.