Why it was recalled
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Product description
DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05
Lot numbers, UPCs & expiration codes
Batch: 6120525, exp 11/2020
Where it was sold
Nationwide USA and Puerto Rico
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-0105-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 17, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 16,986 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0105-2021, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86765
- Address
- 3 Corporate Dr
- Code information
- Batch: 6120525, exp 11/2020
- Postal code
- 60047-8930
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0105-2021
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 16,986 vials
- Termination date
- Aug 25, 2022
- Reason for recall
- Cross Contamination with Other Products: trace amounts of octreotide found during testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Nov 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 24, 2020