FDA Recall D-0235-2024

Pfizer Inc. · New York, NY

Class I — life-threatening Ongoing 875 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake FOrest, IL 60045, NDC 0409-4911-11 (carton), 0409-4911-34 (case).

Lot / code: Lot GY2496, Exp 02/01/2025

Quantity: 24400 Cartons

Reason for recall

Presence of Particulate Matter; identified as glass

Recall record

Recall number: D-0235-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and Puerto Rico.
Recall initiated: 2023-12-21
Classified by FDA Center: 2024-01-17
FDA published: 2024-01-24
Recalling firm: Pfizer Inc.
Firm location: New York, NY

Drug identification

Brand name(s): ATROPINE SULFATE
Generic name(s): ATROPINE SULFATE
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-1630, 0409-9630, 0409-4910, 0409-4911
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

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

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