Doxil Chemotherapy Drug Recalled for Improper Storage Temperature During Shipment
Baxter Healthcare is recalling 472 vials of Doxil chemotherapy medication due to exposure to temperatures exceeding labeled storage conditions during transportation. Affected vials were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a serious oncology drug with a documented CGMP storage deviation, representing a risk of harm (potential loss of drug efficacy or unintended degradation). However, no illnesses or injuries have been reported, keeping the score at 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling Doxil (doxorubicin hydrochloride liposome injection), a prescription chemotherapy medication used to treat certain cancers. The recall affects 472 single-dose vials containing 50 mg in 25 mL that were distributed nationwide.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. During transportation, the affected vials were exposed to temperatures exceeding the labeled storage conditions. Temperature excursions outside specified storage ranges can compromise pharmaceutical stability and drug efficacy.
Healthcare facilities and patients who received vials from lot MKZSU02 (expiration date 6/30/2024) may be affected. Healthcare providers should check their inventory against the recall lot number and quarantine any matching vials. Patients currently taking Doxil should contact their healthcare provider if they have questions about whether they received medication from the affected lot.
No illnesses or injuries have been reported in connection with this recall. The FDA and Baxter Healthcare Corporation are monitoring the situation.
The recalled product
- Product
- DOXIL (DOXORUBICIN HYDROCHLORIDE)
- Brand
- DOXIL
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Oncology / Chemotherapy
- Affected units
- 472
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# MKZSU02
- Exp 6/30/2024
Distribution
Distributed nationwide across the United States.
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