Ganciclovir for Injection — Class II drug recall D-0090-2023
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2023-01-04, distributed nationwide. Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of G
| Recall number | D-0090-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2022-12-16 |
| Classified | 2022-12-27 |
| Reported by FDA | 2023-01-04 |
| Terminated | 2023-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 13,760 vials |
| Reason classes | labeling |
| NDC | 00143-9299, 00143-9299-01, 00143-9299-10 |
| Lot numbers | BQ0006 |
| Expiration dates | 2023-08 |
Product
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
Reason for recall
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
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-0090-2023. 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.