Acyclovir Sodium Injection — Class II drug recall D-0013-2023
Completed recall by AuroMedics Pharma LLC, reported 2022-10-26, distributed nationwide. Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside
| Recall number | D-0013-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2022-09-26 |
| Classified | 2022-10-18 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 89,400 vials |
| Reason classes | specification failure |
| NDC | 55150-0154, 55150-0154-10, 55150-0155, 55150-0155-20 |
| Lot numbers | AC22006 |
| Expiration dates | 2023-08 |
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 for recall
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0013-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.