Recalls / Class III
Class IIID-0412-2015
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.
- Affected lot / code info
- Lot Number: 7801009; Exp: Apr-2015
Why it was recalled
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
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 936 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-02-11
- FDA classified
- 2015-03-13
- Posted by FDA
- 2015-03-25
- Terminated
- 2016-02-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0412-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.