Class II
Ongoing
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
- Company
- Cipla Limited
- Recall Initiated
- October 31, 2025
- Posted
- December 10, 2025
- Recall Number
- D-0197-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4,438 10x1mL cartons
- Firm Location
- Pithampur, District Dhar, India
Reason for Recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
Distribution
Nationwide in the USA
Lot / Code Info
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
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