Drug Enforcement D-0090-2023

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

Status

Terminated

Classification

Class II

Report Date

January 4, 2023

Termination Date

December 6, 2023

Product Information

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
Product quantity
13,760 vials
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.
Recall initiation reason
—
Initial firm notification
—
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
Hikma Pharmaceuticals USA Inc.
Address
2 Esterbrook Ln

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0090-2023
Event ID
91333
Recall initiation date
December 16, 2022
Center classification date
December 27, 2022
Code info
Lot#: BQ0006, Exp 08/2023
More code info
—