US Drug Recall Register
Class II · Moderate risk Terminated Initiated Sep 27, 2022 (4 years ago)

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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)

Recalling firm
Pfizer Inc.
NDC code
0409-5921-16
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0003-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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