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.
For more information visit fda.gov.
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.