Recalls / Class II
Class IID-0090-2023
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
- Brand name
- Ganciclovir
- Generic name
- Ganciclovir Sodium
- Active ingredient
- Ganciclovir Sodium
- Route
- Intravenous
- NDC
- 0143-9299
- FDA application
- ANDA076222
- Affected lot / code info
- Lot#: BQ0006, Exp 08/2023
Why it was recalled
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 13,760 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-12-16
- FDA classified
- 2022-12-27
- Posted by FDA
- 2023-01-04
- Terminated
- 2023-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0090-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.