Recalls / Class III
Class IIID-0105-2021
Product
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
- Brand name
- Doxorubicin Hydrochloride
- Generic name
- Doxorubicin Hydrochloride
- Active ingredient
- Doxorubicin Hydrochloride
- Route
- Intravenous
- NDCs
- 63323-101, 63323-883
- FDA application
- ANDA063277
- Affected lot / code info
- Batch: 6120525, exp 11/2020
Why it was recalled
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 16,986 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2020-11-17
- FDA classified
- 2020-11-24
- Posted by FDA
- 2020-12-02
- Terminated
- 2022-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0105-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.