Why it was recalled
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Product description
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Lot numbers, UPCs & expiration codes
a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
Where it was sold
Nationwide and 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-0676-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 28, 2017
- FDA report date
- Apr 26, 2017
- Quantity
- 278,304 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0676-2017, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 76954
- Address
- 3 Skyline Dr
- Code information
- a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
- Postal code
- 10532-2174
- Report date
- Apr 26, 2017
- Product type
- Drugs
- Recall number
- D-0676-2017
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 278,304 tubes
- Termination date
- Jun 17, 2019
- Reason for recall
- Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 28, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 20, 2017