Recall: D-0197-2026

Class II - Potentially Harmful

Class IIClassification

2025-10-31Initiated

OngoingStatus

Cipla LimitedFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.