Phytonadione Injectable Emulsion recall
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.…
Why was Phytonadione Injectable Emulsion recalled?
Failed Stability Specifications: Observed OOS results: eg results for colour index
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 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.…
- Recalling firm
- Cipla Limited
- Quantity
- 4,438 10x1mL cartons
- Distribution
- Nationwide in the USA
- Recall date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)