Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13

FDA recall notice · announced June 23, 2021 · Avkare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Distributed in Los Angeles California
Lot/code information: Lot: 38617 Exp. 10/2022
Quantity: 10 cartons
Status: Terminated
Products in this recall event:
- Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13 (D-0631-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.