Drug 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
D-0771-2021
Product summary
- Event
- Event 88402
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,152 vials
- Official record key
drug-enforcement:D-0771-2021
Official wording
Reason: Labeling: Not elsewhere classified: Mislabeling
Code information: BL0018
Distribution pattern: USA nationwide
Derived failure modes
-
Labeling or packaging
Mislabeling