Why it was recalled
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Product description
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
Lot numbers, UPCs & expiration codes
Lot #: D301311473, D301411473, Exp 3/2017
Where it was sold
U.S. 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-0790-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 17, 2017
- FDA report date
- May 24, 2017
- Quantity
- 7,776 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0790-2017, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76837
- Address
- 3 Skyline Dr
- Code information
- Lot #: D301311473, D301411473, Exp 3/2017
- Postal code
- 10532-2174
- Report date
- May 24, 2017
- Product type
- Drugs
- Recall number
- D-0790-2017
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 7,776 tubes
- Termination date
- Aug 24, 2021
- Reason for recall
- Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Mar 17, 2017
- Initial firm notification
- Letter
- Center classification date
- May 18, 2017