Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolon...
FDA Drug Recall #D-0676-2017 — Class II — March 28, 2017
Recall Summary
| Recall Number | D-0676-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 28, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Taro Pharmaceuticals U.S.A., Inc. |
| Location | Hawthorne, NY |
| Product Type | Drugs |
| Quantity | 278,304 tubes |
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
Reason for Recall
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Distribution Pattern
Nationwide and Puerto Rico
Lot / 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
Other Recalls from Taro Pharmaceuticals U.S.A., Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0633-2024 | Class III | Hydrocortisone 1% & Acetic Acid 2% Otic Solutio... | Aug 7, 2024 |
| D-0727-2022 | Class III | Clotrimazole and Betamethasone Dipropionate Cre... | Feb 25, 2022 |
| D-0375-2022 | Class I | Clobetasol Propionate Ointment USP, 0.05%, 60g ... | Dec 15, 2021 |
| D-0246-2021 | Class II | Nortriptyline HCl Capsules, USP equivalent to 1... | Jan 8, 2021 |
| D-0158-2021 | Class II | TopCare Health, Athlete's Foot Cream, Clotrimaz... | Nov 17, 2020 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.