REGULATORY INTELLIGENCE·Recall
Cipla USA Inc. Initiates Class II Recall for Phytonadione Injectable Emulsion Due to Stability Failure
Cipla USA Inc. has initiated a Class II recall for 4,438 cartons of Phytonadione Injectable Emulsion, USP 10mg/mL, distributed nationwide. This voluntary action stems from out-of-specification results for color index, indicating a critical stability failure. Procurement and regulatory teams must assess supply chain resilience for this essential Vitamin K product, manufactured by Cipla Ltd. India, to mitigate potential disruption.
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