Agency classClass IIIOur severity:Low FDA (Drugs)·D-0250-2018·Announced 2018-02-14

G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Discoloration

G & W Laboratories is recalling 142,236 tubes of Ciclopirox Olamine Cream USP, 0.77%, due to yellow discoloration. The product is distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is cosmetic discoloration, which aligns with the 'Low' severity criteria for cosmetic defects.

Plain-English summary

G & W Laboratories, Inc. is recalling 142,236 tubes of Ciclopirox Olamine Cream USP, 0.77%. The recall involves 15 g, 30 g, and 90 g tubes of the prescription-only topical medication. The product is manufactured by G & W Laboratories, Inc., located in South Plainfield, NJ.

The recall was initiated because the product is supposed to be a white to off-white homogeneous cream, but it may have intermittent yellow discoloration. This is a Class III recall, which indicates that there is a remote possibility that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the USA and in Puerto Rico. Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product: CICLOPIROX OLAMINE (CICLOPIROX OLAMINE)
Brand: CICLOPIROX OLAMINE
Manufacturer: G & W Laboratories, Inc.
Category: Drug — Topical Antifungal
Hazard: cosmetic-defect
Affected units: 142,236

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 (18)

Lot #: a) 1002896
Exp 09/18
1005797
Exp 05/19
1006100
Exp 07/19
b) 1002561
Exp 06/18
1002897
1005798
1006101
c) 1002898
Exp 10/18
1004283
Exp 12/18
1005837
1006321
1006322

UPCs (1)

0307130638159

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · CICLOPIROX OLAMINE

Low
G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Outdated Insert
FDA (Drugs) · 2017-04-12

Same manufacturer · G & W Laboratories, Inc.

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Same hazard · cosmetic defect