August 2021 FDA Recall Bleomycin by Hikma Pharmaceuticals Usa Inc.
D-0771-2021 - Labeling

This Class III drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on August 5, 2021 for the product Bleomycin. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0771-2021

Reason for Recall
Labeling: Not elsewhere classified: Mislabeling
Initiated
08-05-2021
Reported
09-01-2021
Quantity
1,152 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88402
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# BL0018

Affected Packages Involved in this Recall

0143-9240-01 Bleomycin
0143-9241-01 Bleomycin