Recalls / Class II
Class IID-0095-2023
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
- Brand name
- Acyclovir Sodium
- Generic name
- Acyclovir Sodium
- Active ingredient
- Acyclovir Sodium
- Route
- Intravenous
- NDCs
- 55150-154, 55150-155
- FDA application
- ANDA203701
- Affected lot / code info
- Lot # AC22004, Expiry: 08/2023
Why it was recalled
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 45,250 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-12-28
- FDA classified
- 2023-01-03
- Posted by FDA
- 2023-01-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0095-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.