Recalls / Class III
Class IIID-347-2014
Product
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.
- Brand name
- Ciclopirox
- Generic name
- Ciclopirox
- Active ingredient
- Ciclopirox
- Route
- Topical
- NDC
- 51672-1351
- FDA application
- ANDA090269
- Affected lot / code info
- Lot #: H3135, Exp. January 2015
Why it was recalled
Subpotent. drug
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 850 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-16
- FDA classified
- 2013-12-12
- Posted by FDA
- 2013-12-18
- Terminated
- 2018-05-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-347-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.