Crystallization Complaints Prompt Recall of Injectable Antiviral

The recall was prompted by reports of crystallization in the vials.

Zydus Pharmaceuticals is recalling 4 lots of Acyclovir Sodium Injection 50mg/mL in 10mL and 20mL vials. The recall was prompted by reports of crystallization in the vials.

Acyclovir Sodium Injection is indicated for the treatment of: initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients; severe initial clinical episodes of herpes genitalis in immunocompetent patients; herpes simplex encephalitis; neonatal herpes infections; and varicella-zoster infections in immunocompromised patients.

The recalled product is supplied in single-dose glass vials and includes the following lot numbers and expiration dates:

  • Lot number: L000155; Expiration date: Dec 2021
  • Lot number: L000156; Expiration date: Jan 2022
  • Lot number: L000126; Expiration date: Dec 2021
  • Lot number: L000127; Expiration date: Dec 2021

To date, Zydus has not received any reports of adverse events related to this recall. Administration of crystalized product could potentially lead to injection site inflammation of a vein and local reactions, as well as damage and/or obstruction of blood vessels resulting in blood clots.

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Zydus Pharmaceuticals (USA) Inc. issues voluntary nationwide recall of Acyclovir Sodium Injection, 50 mg/mL due to crystallization. [press release]. Silver Spring, MD: US Food and Drug Administration; March 25, 2021.