Reported Dec 10, 2025 · Ongoing
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At…
Cipla Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla Limited · Plot No. 9 & 10, Pharma Zone Phase Ii · Pithampur, District Dhar · N/A
Is this the product you have?
- Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd
- byCipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd
- forCipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
- Lot codes and dates
Batch # PH0072404APH0082404AExp. Date December 312025
- Amount recalled
- 4,438 10x1mL cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Observed OOS results: eg results for colour index
This product could cause temporary or reversible health problems — stop using it.
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