Presence of Particulate Prompts Recall of Acyclovir Intravenous Product

Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of 1 lot of AuroMedics Acyclovir Sodium Injection 500mg per 10mL (50mg/mL), 10mL single-dose vial due to the presence of a dark red, brown and black particulate inside the vial.

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 and initial clinical episodes of herpes genitalis in immunocompetent patients. 

The recalled lot of AuroMedics Acyclovir Sodium Injection 500mg per 10mL (50mg/mL), 10mL single-dose vial; NDC 55150-154-10; Lot # AC2206; Expiration Date 8/2023, was distributed to wholesalers nationwide from June 8, 2022 to June 13, 2022.

According to the Company, the administration of recalled product may lead to inflammation, allergic reactions, or circulatory system complications which could be life-threatening. To date, the Company has not received reports of any adverse events or identifiable safety concerns related to the recalled product. 

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

Reference

Eugia US LLC issues voluntary nationwide recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), due to the presence of particulate matter. News release. Eugia US LLC. Accessed September 28, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-issues-voluntary-nationwide-recall-acyclovir-sodium-injection-500-mg-10-ml-50-mgml-due