Ganciclovir injection vials contain mislabeled cladribine vials in cartons
Hikma Pharmaceuticals recalled Ganciclovir for Injection due to a labeling error where one vial per carton was mislabeled as Cladribine Injection, creating a risk of incorrect medication administration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medication recall involves a labeling error that creates a risk of incorrect medication administration. No illnesses or injuries have been reported, but the potential for serious harm from administering the wrong medication to a patient warrants a High severity rating.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Ganciclovir for Injection, USP, 500mg per vial packaged in 10-count cartons. The recall is due to a labeling error where one vial in affected cartons bears a label for Cladribine Injection 10mg/mL instead of the correct Ganciclovir labeling.
The affected product is Lot #BQ0006 with expiration date August 2023. Approximately 13,760 vials have been distributed nationwide. The mislabeled vial could be mistakenly administered to a patient, potentially resulting in the wrong medication being given instead of the intended Ganciclovir.
Patients and healthcare providers in possession of affected cartons should stop use immediately and contact Hikma Pharmaceuticals for instructions regarding the return or destruction of the product. Do not administer any vials from affected cartons until the contents have been verified.
The recalled product
- Product
- GANCICLOVIR (GANCICLOVIR SODIUM)
- Brand
- GANCICLOVIR
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Prescription Injection
- Hazard
- mis-labeling
- product-mix-up
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: BQ0006
- Exp 08/2023
Distribution
Distributed nationwide across the United States.
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