Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phytonadione Injectable Emulsion Recalled by Cipla Limited Due to Failed Stability Specifications: Observed OOS results: eg results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cipla Limited directly.
Affected Products
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
Quantity: 4,438 10x1mL cartons
Why Was This Recalled?
Failed Stability Specifications: Observed OOS results: eg results for colour index
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cipla Limited
Cipla Limited has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report