Perrigo Recalls Ciclopirox Shampoo Due to Stability Testing Failures
Perrigo New York, Inc. is recalling specific lots of Ciclopirox shampoo 1% because stability testing revealed out-of-specification related substances.
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 FDA classified this recall as Class III, which by definition indicates the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Perrigo New York, Inc. is recalling 12,252 bottles of Ciclopirox shampoo 1%, 120 mL, prescription only. The product is manufactured by Perrigo in Bronx, NY, and distributed by Perrigo in Allegan, MI. The recall affects specific lots with expiration dates of 02/19.
The recall was initiated due to failed degradation and impurities specifications. Specifically, stability testing identified out-of-specification related substance results. The product was distributed nationwide within the United States.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as Class III by the FDA, indicating the product is not likely to cause adverse health consequences.
The recalled product
- Product
- CICLOPIROX (CICLOPIROX)
- Brand
- CICLOPIROX
- Manufacturer
- Perrigo New York, Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 12,252
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 (3)
- Lot #: 7DT0280
- 7ET0565
- Exp. 02/19
Distribution
Distributed nationwide across the United States.
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