FDAFDA · Food and drugs·Recall number 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 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Published December 10, 2025 · Recall initiated: October 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Observed OOS results: eg results for colour index
What to do
Voluntary: Firm initiated
Recall details
- Brand
- PHYTONADIONE
- Manufacturer
- Cipla Limited
- Distributor
- Nationwide in the USA
- Lot
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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