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The company is recalling the product because of crystallization in vials.
Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ) announced on March 24, 2021 that it was voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, in 10 mL and 20 mL vials. The recall is a result of complaints of crystallization in vials. According to the company, administration of crystallized product could result in life-threatening adverse reactions, such as obstruction of blood vessels and blood clots.
The recalled product is packaged in single-dose glass vials. Specific information on the recalled lots can be found on FDA’s website. It was distributed nationwide in the United States to Cardinal Health, AmerisourceBergen Drug Corporation, and Morris & Dickson Company LLC. As of the date of the company announcement, the company has not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch program.
Acyclovir Sodium Injection, 50 mg/mL is used to treat herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection, and varicella-zoster (shingles) infections in immunocompromised patients, according to the company.