FDA Recall D-0565-2024

Pfizer Inc. · New York, NY

Class II Ongoing 724 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09

Quantity: 220,400 cartridges

Reason for recall

Lack of Assurance of Sterility-The potential for incomplete crimp seals.

Recall record

Recall number: D-0565-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide and Puerto Rico.
Recall initiated: 2024-05-20
Classified by FDA Center: 2024-06-22
FDA published: 2024-07-03
Recalling firm: Pfizer Inc.
Firm location: New York, NY

Drug identification

Brand name(s): LABETALOL HYDROCHLORIDE
Generic name(s): LABETALOL HYDROCHLORIDE
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-2339
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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