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FDARecalled Dec 10, 2025 · #D-0197-2026

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...

Hazard

Class II — temporary health risk

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Description

Failed Stability Specifications: Observed OOS results: eg results for colour index Classification: Class II Distribution: Nationwide in the USA

Product details

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
Type
Drugs
Manufacturer
Cipla Limited
Model numbers
UPCs