Home / Recalls / Cipla Limited / D-0197-2026

D-0197-2026 Class II Ongoing

Recalled by Cipla Limited — Pithampur, District Dhar

Recall Details

Product Type: Drugs
Report Date: December 10, 2025
Initiation Date: October 31, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,438 10x1mL cartons

Product Description

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

Distribution Pattern

Nationwide in the USA

Code Information

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