FDAFDA · Food and drugs·Recall number D-0565-2024
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
Published July 3, 2024 · Recall initiated: May 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LABETALOL HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Distributor
- US Nationwide and Puerto Rico.
- Lot
- Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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