Why it was recalled
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Product description
Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
Lot numbers, UPCs & expiration codes
Lot# MKZSU02, Exp 6/30/2024
Where it was sold
Nationwide in the USA
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-0048-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 472 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0048-2024, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 93201
- Address
- 1 Baxter Pkwy
- Code information
- Lot# MKZSU02, Exp 6/30/2024
- Postal code
- 60015-4625
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0048-2024
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 472 vials
- Termination date
- Dec 22, 2025
- Reason for recall
- CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 24, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2023