Cipla USA recalled 4,438 cartons of Phytonadione Injectable Emulsion on October 31, 2025. The product failed stability specifications, raising concerns about its safety. Consumers and healthcare providers must stop using the product immediately and seek guidance.
Failed Stability Specifications: Observed OOS results: eg results for colour index
Consumers and healthcare providers should stop using this product immediately. Contact Cipla Limited or your healthcare provider for guidance
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Phytonadione Injectable Emulsion is a medication used to treat vitamin K deficiency and support patients on anticoagulants. It is typically administered in clinical settings.
The product's failure in stability specifications means it may not perform as intended, potentially leading to ineffective treatment.
This recall is not part of a broader industry pattern.
Consumers must cease use of the product immediately to avoid health risks. The recall could lead to disruption in treatment for individuals relying on vitamin K supplementation.
Batch numbers and expiration dates can be found on the vial label or carton packaging.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep records of your purchase, including receipts and any communications with the manufacturer or retailer.
This recall involves Phytonadione Injectable Emulsion, USP 10mg/mL, in 10x1 mL single-dose vials. The vials have NDC# 69097-708-31, and the cartons have NDC 69097-708-96. This product was manufactured by Cipla Ltd. in India for Cipla USA, Inc. and has a lot number PH0072404A.
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