Why it was recalled
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Product description
Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
Lot numbers, UPCs & expiration codes
Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
Where it was sold
US & Puerto Rico
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-0116-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 13, 2016
- FDA report date
- Nov 9, 2016
- Quantity
- 15,576 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0116-2017, exactly as published.
Show all FDA fields
- City
- Brampton
- Status
- Terminated
- Country
- Canada
- Event ID
- 75349
- Address
- 130 East Dr
- Code information
- Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
- Report date
- Nov 9, 2016
- Product type
- Drugs
- Recall number
- D-0116-2017
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals, Inc.
- Product quantity
- 15,576 units
- Termination date
- Jun 15, 2018
- Reason for recall
- Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
- Distribution pattern
- US & Puerto Rico
- Recall initiation date
- Sep 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2016