Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by:...
FDA Recall #D-0197-2026 — Class II — October 31, 2025
Product Description
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
Recalling Firm
Cipla Limited — Pithampur, District Dhar
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,438 10x1mL cartons
Distribution
Nationwide in the USA
Code Information
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated