FDA recall D-0095-2023

Eugia US LLC · Class II · drug

Product

Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

Reason for recall

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2022-12-28
Report date: 2023-01-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2023