Drug recall D-0095-2023

Class II Ongoing reported Jan 11, 2023

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

Lots and codes

Lot # AC22004, Expiry: 08/2023

Recall details

Recalling firm
Eugia US LLC, East Windsor, NJ
Quantity
45,250 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
December 28, 2022

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