Recalls / Class II
Class IID-0565-2024
Product
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
- Brand name
- Labetalol Hydrochloride
- Generic name
- Labetalol Hydrochloride
- Active ingredient
- Labetalol Hydrochloride
- Route
- Intravenous
- NDC
- 0409-2339
- FDA application
- ANDA075239
- Affected lot / code info
- Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
Why it was recalled
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 220,400 cartridges
- Distribution pattern
- US Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2024-05-20
- FDA classified
- 2024-06-22
- Posted by FDA
- 2024-07-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0565-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.