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March 25, 2021Zydus Pharmaceuticals Recalls Four Lots of Acyclovir Sodium Injection
March 25, 2021 – Zydus Pharmaceuticals has voluntarily recalled four lots of Acyclovir Sodium Injection, 50mg/mL, 10mL and 20mL vials, after receiving complaints of crystalized contents.
Acyclovir sodium injection is indicated to treat multiple types of herpes virus infections. Administering a crystalized injection of the product to a patient could be life-threatening. Possible adverse events include injection site inflammation of a vein, local reactions, damage and/or obstruction of blood vessels, blood clots (including in the lungs), passage of particulate matter into the blood stream, stroke, heart attack, decreased liver or kidney function, or the death of tissues or cells. As of the date of the recall, Zydus had not received any reports of adverse events related to the affected product.
Zydus has advised hospitals to stop using the recalled product immediately and call their recall coordinating center. Questions regarding the recall can be directed to Zydus at 1-877-993-8779 or medicalaffairs@zydususa.com. Patients should contact their healthcare provider if they have experienced any problems that may be related to receiving the recalled acyclovir sodium. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
A full copy of the recall is available on the FDA's website.