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
Reported: January 4, 2023 Initiated: December 16, 2022 #D-0090-2023
Product 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
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.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 13,760 vials
- Distribution
- USA Nationwide
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 13,760 vials.
Why was this product recalled? ▼
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 4, 2023. Severity: Moderate. Recall number: D-0090-2023.
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