Cipla Limited has recalled 4,438 cartons of Phytonadione Injectable Emulsion, USP 10mg/mL, which is a vitamin K1 injection used to treat bleeding disorders. The recall was initiated because the product failed stability testing due to results outside of specification for its color index. This issue affects specific batches PH0072404A and PH0082404A with an expiration date of December 31, 2025.
A failed color index indicates the product may have degraded or changed chemically, which could potentially impact its safety or effectiveness when administered to a patient. No specific injuries or adverse reactions have been reported to date.
Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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