Pfizer Inc.: Drug Recall

Recall #D-0003-2023 · 09/27/2022

Class II: Risk

Recall Details

Recall Number
D-0003-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Pfizer Inc.
Status
Terminated
Date Initiated
09/27/2022
Location
New York, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
103,150 10 mL vials

Reason for Recall

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

Product Description

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)

Distribution Pattern

Distributed in the United States and Puerto Rico.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.