Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Product description
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
Lot numbers, UPCs & expiration codes
Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.
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-1370-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 5, 2015
- FDA report date
- Sep 2, 2015
- Quantity
- 16,320 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1370-2015, exactly as published.
Show all FDA fields
- City
- Brampton
- Status
- Terminated
- Country
- Canada
- Event ID
- 71845
- Address
- 130 East Dr
- Code information
- Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.
- Report date
- Sep 2, 2015
- Product type
- Drugs
- Recall number
- D-1370-2015
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals, Inc.
- Product quantity
- 16,320 Bottles
- Termination date
- Apr 3, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 5, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 25, 2015