Pfizer Inc.: Drug Recall
Recall #D-0565-2024 · 05/20/2024
Class II: Risk
Recall Details
- Recall Number
- D-0565-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Pfizer Inc.
- Status
- Ongoing
- Date Initiated
- 05/20/2024
- Location
- New York, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 220,400 cartridges
Reason for Recall
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Product Description
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
Distribution Pattern
US Nationwide and Puerto Rico.
Other Recalls by Pfizer Inc.
- Class II: Risk 08/04/2025
- Class II: Risk 08/04/2025
- Class II: Risk 07/10/2025
- Class II: Risk 07/10/2025
- Class II: Risk 05/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.