FDA Drug recall D-0013-2023
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hig…
- FDA Drug
- Class II
- completed
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hig… by Auromedics Pharma, citing presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0013-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-09-26 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
Product
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.
Reason
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Identifiers
| ndc | 55150-154-10 |
|---|---|
| ndc | 55150-155-20 |
| code_info | Lot: AC22006, Exp 08/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2023%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.