FDA Drug recall D-0676-2017
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (N…
- FDA Drug
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (N… by Taro Pharmaceuticals U, citing failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0676-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-28 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
Product
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
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Identifiers
| ndc | 51672-1272-1 |
|---|---|
| ndc | 51672-1272-2 |
| ndc | 51672-1272-3 |
| ndc | 51672-1263-1 |
| ndc | 51672-1263-2 |
| ndc | 51672-1263-3 |
| code_info | a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I41…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0676-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.