Famciclovir tablets — Class II drug recall D-0610-2017
Terminated recall by AVKARE Inc., reported 2017-03-29, distributed nationwide. Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
| Recall number | D-0610-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2017-02-15 |
| Classified | 2017-03-22 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2022-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 116 cartons |
| Reason classes | specification failure |
| NDC | 50268-0307-13 |
| Lot numbers | 15152 |
| Expiration dates | 2018-02 |
Product
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Reason for recall
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
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-0610-2017. 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.