Why it was recalled
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
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
Lot numbers, UPCs & expiration codes
Lot # AC22004, Expiry: 08/2023
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0095-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 28, 2022
- FDA report date
- Jan 11, 2023
- Quantity
- 45,250 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0095-2023, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 91406
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot # AC22004, Expiry: 08/2023
- Postal code
- 08520-1401
- Report date
- Jan 11, 2023
- Product type
- Drugs
- Recall number
- D-0095-2023
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 45,250 vials
- Reason for recall
- Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 28, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 3, 2023