Class I · High risk Ongoing
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake…
Reason Presence of particulate matter: glass
Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not elsewhere classified: Mislabeling
What was recalled
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
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- NDC code
- 0143-9240-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0771-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bleomycin recalls
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Class II · Moderate risk Terminated
BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bleomycin Sulfate 1unit/ml
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
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