Phytonadione Tablets 5 mg — Class III drug recall D-0631-2021
Terminated recall by AVKARE Inc., reported 2021-06-23, distributed in CA. Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
| Recall number | D-0631-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2021-06-09 |
| Classified | 2021-06-16 |
| Reported by FDA | 2021-06-23 |
| Terminated | 2023-06-02 |
| Distributed | CA |
| Quantity | 10 cartons |
| Reason classes | specification failure |
| NDC | 50268-0661-13 |
| Lot numbers | 38617 |
| Expiration dates | 2022-10 |
Product
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Reason for recall
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
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-0631-2021. 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.