FDAHealthOctober 31, 2025
Cipla Limited — 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, In
⚠️ Failed Stability Specifications: Observed OOS results: eg results for colour index
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 31, 2025
Nationwide in the USA
What's affected?
- 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
- Brand
- PHYTONADIONE
- Lot code
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Additional details
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4,438 10x1mL cartons.
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