Recall: D-0771-2021

Class III - Minor Violations

Class IIIClassification

2021-08-05Initiated

TerminatedStatus

Hikma Pharmaceuticals USA Inc.Firm

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

Labeling: Not elsewhere classified: Mislabeling

Distribution

USA nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.