Class IIReported 2025-12-10

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96

Reason for Recall

Failed Stability Specifications: Observed OOS results: eg results for colour index

Recall Number

D-0197-2026

Classification

Class II

Status

Ongoing