FDAClass IIMay 13, 2015

C-Topical 4% CII recall: Labeling Error

C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc.…

Why was C-Topical 4% CII recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 14834012, Exp 01/2016

Product
C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc.…
Recalling firm
Cody Laboratories, Inc.
Quantity
19,139 bottles
Distribution
Nationwide
Recall date
May 13, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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