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

FDA recall notice · announced January 11, 2023 · Eugia Us

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # AC22004, Expiry: 08/2023
Quantity: 45,250 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0095-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.