Recalls / Class III
Class IIID-0512-2019
Product
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
- Brand name
- Ciclopirox
- Generic name
- Ciclopirox
- Active ingredient
- Ciclopirox
- Route
- Topical
- NDC
- 45802-401
- FDA application
- ANDA078594
- Affected lot / code info
- Lot #: 7DT0280, 7ET0565, Exp. 02/19
Why it was recalled
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Recalling firm
- Firm
- Perrigo New York, Inc.
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Bathgate Ave, Bronx, New York 10457-7512
Distribution
- Quantity
- 12252 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-02-13
- FDA classified
- 2019-02-20
- Posted by FDA
- 2019-02-27
- Terminated
- 2021-09-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0512-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.