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
Reported: September 1, 2021 Initiated: August 5, 2021 #D-0771-2021
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
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 1,152 vials
- Distribution
- USA nationwide
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product 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. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 1,152 vials.
Why was this product recalled? ▼
Labeling: Not elsewhere classified: Mislabeling
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 1, 2021. Severity: Low. Recall number: D-0771-2021.
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