D-0771-2021 Class III Terminated
FDA drug recall D-0771-2021 was initiated by Hikma Pharmaceuticals USA Inc. on August 5, 2021 and is designated Class III. Reason for recall: Labeling: Not elsewhere classified: Mislabeling The recall status is terminated (terminated June 8, 2023). Affected quantity: 1,152 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- September 1, 2021
- Initiation Date
- August 5, 2021
- Termination Date
- June 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,152 vials
Product Description
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 Pattern
USA nationwide
Code Information
BL0018