Dr. Reddy's Laboratories, Inc. has recalled 2,838 ampules of Phytonadione Injectable Emulsion USP (10 mg/mL), a vitamin K1 supplement used to treat certain bleeding or blood-clotting problems. The recall was initiated after 12-month stability testing revealed that the aluminum content in the medication exceeded safe specifications. While no injuries have been reported to date, the product was distributed nationwide to hospitals, pharmacies, and clinics.
The medication contains aluminum levels higher than allowed by safety standards. Excessive aluminum exposure can lead to toxicity, particularly in patients with impaired kidney function or newborns who receive large amounts of intravenous fluids.
Recall #: D-0007-2023. Distributed by Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.
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Sources: FDA iRES · Raw API Response
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