Status
Ongoing
Drug Enforcement D-0565-2024
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Classification
Class II
Report Date
July 3, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 220,400 cartridges
- Reason for recall
- Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Pfizer Inc.
- Address
-
235 East 42nd Street
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0565-2024
- Event ID
- 94681
- Recall initiation date
- May 20, 2024
- Center classification date
- June 22, 2024
- Code info
- Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
- More code info
- —