Flurandrenolide Ointment USP — Class II drug recall D-0356-2021
Ongoing recall by Teligent Pharma, Inc., reported 2021-04-28, distributed nationwide. Failed Impurities/Degradation Specifications:
| Recall number | D-0356-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teligent Pharma, Inc., Buena, NJ, United States |
| Recall initiated | 2021-04-09 |
| Classified | 2021-04-28 |
| Reported by FDA | 2021-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 3,432 tubes |
| Reason classes | specification failure |
| NDC | 52565-0017-60 |
| Lot numbers | 13974 |
| Expiration dates | 2021-07 |
Product
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Reason for recall
Failed Impurities/Degradation Specifications:
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-0356-2021. 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.