drugs Class III Updated 2015-03-25

Mylan Institutional LLC recalls DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 m

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 7801009; Exp: Apr-2015
View official government recall

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