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
Reported: October 25, 2023 Initiated: August 24, 2023 #D-0048-2024
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
Reason for Recall
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 472 vials
- Distribution
- Nationwide in the USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Baxter Healthcare Corporation. Units affected: 472 vials.
Why was this product recalled? ▼
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 25, 2023. Severity: Moderate. Recall number: D-0048-2024.
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