Why it was recalled
Subpotent Drug
Product description
¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.
Lot numbers, UPCs & expiration codes
Lot # A5192-18338, Expiry: 12/2016
Where it was sold
U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA
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-0950-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 31, 2016
- FDA report date
- Jun 8, 2016
- Quantity
- 62,800 Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0950-2016, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 73829
- Address
- 3 Skyline Dr
- Code information
- Lot # A5192-18338, Expiry: 12/2016
- Postal code
- 10532-2174
- Report date
- Jun 8, 2016
- Product type
- Drugs
- Recall number
- D-0950-2016
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 62,800 Tubes
- Termination date
- Jun 6, 2018
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.
- Distribution pattern
- U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA
- Recall initiation date
- Mar 31, 2016
- Initial firm notification
- Letter
- Center classification date
- May 31, 2016