Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie G
Summary
The FDA issued a Class III for Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only by Hikma Pharmaceuticals USA Inc.. Reason: Labeling: Not elsewhere classified: Mislabeling.
Details
Source
Drug Recall
External ID
D-0771-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
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
Lot/Code Info: BL0018
Quantity Affected: 1,152 vials
Reason for Recall
Labeling: Not elsewhere classified: Mislabeling
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-05
Company
Cherry Hill, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Hikma Pharmaceuticals USA Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Pharmaceuticals USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Pharmaceuticals USA Inc. have FDA actions?
Hikma Pharmaceuticals USA Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0771-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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