ACYCLOVIR SODIUM Recall D-0095-2023
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
ACYCLOVIR SODIUM Recall D-0095-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0095-2023 |
| Event ID | 91406 |
| Brand | ACYCLOVIR SODIUM |
| Generic Name | ACYCLOVIR SODIUM |
| Manufacturer | ACYCLOVIR SODIUM |
| Original Package? | 1 |
| Active Substance | ACYCLOVIR SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Quantity | 45,250 vials |
| Recall Reason | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial |
| Drug Classification | Class II |
| Drug Code Info | 20230111 |
| Product NDC | 55150-154 55150-155 |
| Drug UPC | 0355150155200 0355150154104 |
| Recall Initiation Date | 20221228 |
| Report Date | 20230111 |
| Classification Date | 20230103 |
| Address | 279 Princeton Hightstown Rd East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Eugia US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 927L42J563 |
| Drug Application Number | ANDA203701 |
| Structured Product Labeling (SPL ID) | aa3fd121-088f-4b44-9630-a7d152d682de |
| Structured Product Labeling (SPL Set ID) | ae921e4e-b8ae-4a45-acc1-32e5e719812b |
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