Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Cipla Limited

NDC code

69097-708-31

Origin

India

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0197-2026

Other Phytonadione recalls

See all

Class II · Moderate risk Terminated Dec 27, 2022

VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300…

Reason Lack of sterility assurance

Sentara Infusion Services D-0324-2023

Class III · Low risk Completed Sep 14, 2022

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's…

Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Dr. Reddy's Laboratories, Inc. NDC 43598-405-16 D-0007-2023

Class III · Low risk Terminated Jun 9, 2021

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.

AVKARE Inc. NDC 50268-661-13 D-0631-2021

Class III · Low risk Terminated Jun 8, 2021

Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant…

Reason Failed Impurities/Degradation Specifications

Bausch Health Companies, Inc. NDC 68682-170-30 D-0639-2021

Class III · Low risk Terminated Jun 8, 2021

Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC…

Reason Failed Impurities/Degradation Specifications

Bausch Health Companies, Inc. NDC 0187-1704-05 D-0638-2021