Cody Laboratories C-Topical CII Recall: FDA Class II

Why it was recalled

Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL

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

Lot numbers, UPCs & expiration codes

Lot 14834012, Exp 01/2016

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0992-2015
Classification: Class II
Status: Terminated
Recall initiated: Mar 31, 2015
FDA report date: May 13, 2015
Quantity: 19,139 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Cody Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0992-2015, exactly as published.

Show all FDA fields

City: Cody
State: WY
Status: Terminated
Country: United States
Event ID: 70921
Address: 601 Yellowstone Ave
Code information: Lot 14834012, Exp 01/2016
Postal code: 82414-9321
Report date: May 13, 2015
Product type: Drugs
Recall number: D-0992-2015
Classification: Class II
Recalling firm: Cody Laboratories, Inc.
Product quantity: 19,139 bottles
Termination date: Oct 14, 2015
Reason for recall: Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: Nationwide
Recall initiation date: Mar 31, 2015
Initial firm notification: E-Mail
Center classification date: May 5, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0992-2015, published May 13, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Cody Laboratories C-Topical 4% CII Recall

Summary