RecallDepth
Class III Terminated

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.

Company
Mylan Institutional Llc
Recall Initiated
February 11, 2015
Posted
March 25, 2015
Recall Number
D-0412-2015
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
936 vials
Firm Location
Rockford, IL, United States

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

Distribution

Nationwide

Lot / Code Info

Lot Number: 7801009; Exp: Apr-2015

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