FDA recall D-0771-2021

Product

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

Reason for recall

Labeling: Not elsewhere classified: Mislabeling

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2021-08-05

Report date

2021-09-01

Termination date

2023-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cherry Hill, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0771-2021