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
This recall is currently active, issued January 11, 2023. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- December 28, 2022
- Posted
- January 11, 2023
- Recall Number
- D-0095-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 45,250 vials
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Distribution
Nationwide in the USA
Lot / Code Info
Lot # AC22004, Expiry: 08/2023
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