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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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.
The product failed stability specifications, specifically observed out-of-specification results related to color index. This implies potential degradation that may affect efficacy and safety.
No specific incidents of injury or adverse effects have been reported. However, the high hazard level indicates serious safety concerns.
Stop using the Phytonadione Injectable Emulsion immediately. Contact Cipla Limited or your healthcare provider for further guidance and assistance.
For more information, consumers can visit the FDA website or contact Cipla USA, Inc. directly at their customer service number.
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