G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Outdated Insert
G & W Laboratories is recalling 230,700 tubes of Ciclopirox Olamine Cream because some lots were packaged with an out-of-date package insert.
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 The hazard is limited to packaging documentation (outdated insert) rather than a physical or chemical defect in the drug itself.
Plain-English summary
G & W Laboratories, Inc. is recalling 230,700 tubes of Ciclopirox Olamine Cream USP, 0.77%. The product is available in 15 g, 30 g, and 90 g tubes and is distributed nationwide in the USA and Puerto Rico.
The recall was initiated because specific product lots were packaged with an out-of-date package insert. This is a labeling issue involving incorrect or missing package insert information.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- CICLOPIROX OLAMINE (CICLOPIROX OLAMINE)
- Brand
- CICLOPIROX OLAMINE
- Manufacturer
- G & W Laboratories, Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 230,700
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 (20)
- Lot #: a) 63800090
- Exp 04/17
- 63800095
- Exp 11/17
- 1000573
- Exp 02/18
- 1002560
- Exp 06/18
- b) 63800090
- 63800092
- Exp 07/17
- 63800093
- Exp 08/17
- 1000574
- 1001772
- Exp 05/18
- c) 63800089
- Exp 03/17
- 63800091
- 63800094
UPCs (1)
- 0307130638159
Distribution
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