D-0095-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 11, 2023
- Initiation Date
- December 28, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,250 vials
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot # AC22004, Expiry: 08/2023