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
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.
Lot numbers, UPCs & expiration codes
Lot Number: 7801009; Exp: Apr-2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0412-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 11, 2015
- FDA report date
- Mar 25, 2015
- Quantity
- 936 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-0412-2015, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70565
- Address
- 4901 Hiawatha Dr
- Code information
- Lot Number: 7801009; Exp: Apr-2015
- Postal code
- 61103-1287
- Report date
- Mar 25, 2015
- Product type
- Drugs
- Recall number
- D-0412-2015
- Classification
- Class III
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- 936 vials
- Termination date
- Feb 9, 2016
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 11, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2015