Why it was recalled
Subpotent. drug
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: H3135, Exp. January 2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-347-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 16, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 850 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-347-2014, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66519
- Address
- 3 Skyline Dr
- Code information
- Lot #: H3135, Exp. January 2015
- Postal code
- 10532-2174
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-347-2014
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 850 bottles
- Termination date
- May 18, 2018
- Reason for recall
- Subpotent. drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 16, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 12, 2013