Recalls / Class III
Class IIID-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
- Brand name
- Bleomycin
- Generic name
- Bleomycin
- Active ingredient
- Bleomycin Sulfate
- Route
- Intramuscular, Intrapleural, Intravenous, Subcutaneous
- NDCs
- 0143-9240, 0143-9241
- FDA application
- ANDA065042
- Affected lot / code info
- BL0018
Why it was recalled
Labeling: Not elsewhere classified: Mislabeling
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, N/A, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 1,152 vials
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2021-08-05
- FDA classified
- 2021-08-26
- Posted by FDA
- 2021-09-01
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0771-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.