Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. L
Summary
The FDA issued a Class II for Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, by Pfizer Inc.. Reason: Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial..
Details
Source
Drug Recall
External ID
D-0003-2023
Action Date
2022-10-12
Status
Terminated
Category
drug
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)
Lot/Code Info: Lot: 30-137-DK Exp. 1 DEC. 2022
Quantity Affected: 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.
Distribution
Distributed in the United States and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-27
Company
New York, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 33 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pfizer Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pfizer Inc. have FDA actions?
Pfizer Inc. has 45 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0003-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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