Drug recall D-0412-2015

Class III Terminated reported Mar 25, 2015

Product

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.

Reason for recall

Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL

Lots and codes

Lot Number: 7801009; Exp: Apr-2015

Recall details

Recalling firm
Mylan Institutional LLC, Rockford, IL
Quantity
936 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 11, 2015
Terminated
February 9, 2016