D-0412-2015 Class III Terminated
FDA drug recall D-0412-2015 was initiated by Mylan Institutional LLC on Feb 11, 2015 and is designated Class III. 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 The recall status is terminated (terminated Feb 9, 2016). Affected quantity: 936 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 25, 2015
- Initiation Date
- Feb 11, 2015
- Termination Date
- Feb 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 936 vials
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot Number: 7801009; Exp: Apr-2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0412-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026