Status
Ongoing
Drug Enforcement D-0095-2023
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Classification
Class II
Report Date
January 11, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 45,250 vials
- Reason for recall
- Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Eugia US LLC
- Address
-
279 Princeton Hightstown Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0095-2023
- Event ID
- 91406
- Recall initiation date
- December 28, 2022
- Center classification date
- January 3, 2023
- Code info
- Lot # AC22004, Expiry: 08/2023
- More code info
- —