Cody Laboratories Recalls C-Topical 4% Cocaine Hydrochloride Due to Labeling Error
Cody Laboratories is recalling 19,139 bottles of C-Topical 4% cocaine hydrochloride because they were incorrectly labeled as 10 mL instead of 4 mL.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (volume mislabeling) rather than a contamination or structural defect, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
Cody Laboratories, Inc. is recalling 19,139 bottles of C-Topical 4% CII (cocaine hydrochloride) topical solution. The product is a 4 ml bottle, NDC 0527-1728-74, manufactured for Lannett Company, Inc. The affected lot is 14834012 with an expiration date of 01/2016.
The recall was initiated due to a labeling error where the bottles were incorrectly labeled as 10 mL instead of the correct 4 mL volume. This mislabeling could lead to incorrect dosing if the volume indication is relied upon for administration.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or credit.
The recalled product
- 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
- Manufacturer
- Cody Laboratories, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 19,139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 14834012
- Exp 01/2016
Distribution
Distributed nationwide across the United States.
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