Reported Jul 3, 2024 · Ongoing
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with…
Pfizer Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703
Is this the product you have?
- 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
- NDC0409-2339-24
- Lot codes and dates
Lot#: HJ7566Exp 2025/05 Lot#: HN8747Exp 2025/09 Lot#: HN8749Exp 2025/09
- Amount recalled
- 220,400 cartridges
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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