GANCICLOVIR SODIUM Recall D-0090-2023
Description: Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
GANCICLOVIR SODIUM Recall D-0090-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0090-2023 |
| Event ID | 91333 |
| Brand | GANCICLOVIR |
| Generic Name | GANCICLOVIR SODIUM |
| Manufacturer | GANCICLOVIR SODIUM |
| Original Package? | 1 |
| Active Substance | GANCICLOVIR SODIUM |
| Drug Route | INTRAVENOUS |
| Distribution | USA Nationwide |
| Quantity | 13,760 vials |
| Recall Reason | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. |
| Drug Classification | Class II |
| Drug Code Info | 20230104 |
| Product NDC | 0143-9299 |
| Recall Initiation Date | 20221216 |
| Report Date | 20230104 |
| Classification Date | 20221227 |
| Address | 2 Esterbrook Ln Cherry Hill, NJ 08003-4002 United States |
| Recalling Firm | Hikma Pharmaceuticals USA Inc. |
| Unique Ingredient Identifier | 02L083W284 |
| Drug Application Number | ANDA076222 |
| Structured Product Labeling (SPL ID) | 0fff71bc-b705-4d81-ab82-83f218f3160d |
| Structured Product Labeling (SPL Set ID) | 4f8219ca-6780-4131-8962-9c3fdd0a84dd |
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