Drug 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
D-0095-2023
Product summary
- Firm
- Eugia US LLC
- Event
- Event 91406
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45,250 vials
- Official record key
drug-enforcement:D-0095-2023
Official wording
Reason: Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Code information: Lot # AC22004, Expiry: 08/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter