FDA-Drug2025-12-10Class II
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
Cipla Limited
Hazard
Failed Stability Specifications: Observed OOS results: eg results for colour index
Sold states
Nationwide in the USA
Affected count
4,438 10x1mL cartons
Manufactured in
Plot No. 9 & 10, Pharma Zone Phase Ii, Section Iiii, Indore Special Economic Zone, Pithampur, District Dhar, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2026Don't want to check this manually?
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