PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 11, 2023 Initiated: December 28, 2022 #D-0095-2023

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

Details

Recalling Firm
Eugia US LLC
Units Affected
45,250 vials
Distribution
Nationwide in the USA
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Eugia US LLC. Units affected: 45,250 vials.
Why was this product recalled?
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Which agency issued this recall?
This recall was issued by the FDA Drug on January 11, 2023. Severity: Moderate. Recall number: D-0095-2023.