FDA Drug recall D-0631-2021
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478
- FDA Drug
- Class III
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class III recall of Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478 by Avkare, citing failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0631-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-06-09 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | CA |
Product
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Reason
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Identifiers
| code_info | Lot: 38617 Exp. 10/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0631-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.