FDA recall D-0235-2024

Pfizer Inc. · Class I · drug

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).

Reason for recall

Presence of Particulate Matter; identified as glass

Distribution

Nationwide in the USA and Puerto Rico.

Key facts

Status
Ongoing
Initiation date
2023-12-21
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0235-2024