FDAClass IIISeptember 1, 2021

Bleomycin for Injection recall: Labeling Error

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

Why was Bleomycin for Injection recalled?

Labeling: Not elsewhere classified: Mislabeling

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

BL0018

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
Recalling firm
Hikma Pharmaceuticals USA Inc.
Quantity
1,152 vials
Distribution
USA nationwide
Recall date
September 1, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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