Nystatin and Triamcinolone Acetonide Ointment — Class II drug recall D-0695-2022
Terminated recall by Teligent Pharma, Inc., reported 2022-03-30, distributed nationwide. cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability
| Recall number | D-0695-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2022-03-15 |
| Classified | 2022-03-21 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 217,184 tubes |
| Reason classes | cgmp, specification failure |
| NDC | 52565-0042-15, 52565-0042-30, 52565-0042-60 |
| Expiration dates | 2022-02-28, 2022-03-31, 2022-05-31, 2022-06-30, 2022-09-30, 2022-11-30, 2023-01-31, 2023-02-28, 2023-03-31, 2023-04-30 |
Product
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Reason for recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0695-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.