Recall: D-0095-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-28Initiated

OngoingStatus

Eugia US LLCFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.