Drug recall D-0197-2026

Class II Ongoing reported Dec 10, 2025

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

Reason for recall

Failed Stability Specifications: Observed OOS results: eg results for colour index

Lots and codes

Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

Recall details

Recalling firm
Cipla Limited, Pithampur, District Dhar
Quantity
4,438 10x1mL cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
October 31, 2025

Related products