Voriconazole Tablets — Class III drug recall D-1094-2017
Terminated recall by AVKARE Inc., reported 2017-08-23, distributed nationwide. Failed impurities/degradation specifications: Out of specification for a related compound C.
| Recall number | D-1094-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2017-07-19 |
| Classified | 2017-08-15 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 50268-0804-12 |
| Lot numbers | 16933, 17054 |
| Expiration dates | 2018-07, 2018-08 |
Product
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
Reason for recall
Failed impurities/degradation specifications: Out of specification for a related compound C.
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-1094-2017. 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.