FDA recall D-0003-2023

Product

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

Reason for recall

Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.

Distribution

Distributed in the United States and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2022-09-27

Report date

2022-10-12

Termination date

2024-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2023