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.
What this means for you
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
- 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
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