FDA Drug recall D-0095-2023
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL)
- FDA Drug
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL) by Eugia Us, citing presence of Particulate Matter: Customer complaint of dark particles found inside the vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0095-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-28 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
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
Reason
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Identifiers
| ndc | 55150-154-10 |
|---|---|
| ndc | 55150-155-20 |
| code_info | Lot # AC22004, Expiry: 08/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0095-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.