United StatesPhytonadione Injectable Emulsion, USP 10 mg/mL, 10 x 1 mL single‑dose vial (Vial NDC 69097‑708‑31; Carton NDC 69097‑708‑96), batches PH0072404A and PH0082404A, exp. 12/31/2025, manufactured by Cipla Ltd. India for Cipla USA, is being recalled nationwide in the United States. The recall was initiated after observed out‑of‑specification stability results, including results for colour index.
What's being recalled
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
Recalling firm: Cipla Limited, Pithampur, District Dhar, India.
How to identify it
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
The hazard
Failed Stability Specifications: Observed OOS results: eg results for colour index
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)