C-Topical 4% CII — Class II drug recall D-0992-2015
Terminated recall by Cody Laboratories, Inc., reported 2015-05-13, distributed nationwide. Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
| Recall number | D-0992-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cody Laboratories, Inc., Cody, WY, United States |
| Recall initiated | 2015-03-31 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 19,139 bottles |
| Reason classes | labeling |
| NDC | 00527-1728-74 |
| Lot numbers | 14834012 |
| Expiration dates | 2016-01 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0992-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.