Product: 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 initiated: 20251031
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated