Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distr...
FDA Recall #D-0095-2023 — Class II — December 28, 2022
Product Description
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
Recalling Firm
Eugia US LLC — East Windsor, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
45,250 vials
Distribution
Nationwide in the USA
Code Information
Lot # AC22004, Expiry: 08/2023
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated