Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution an
Summary
The FDA issued a Class II for Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intr by BE PHARMACEUTICALS AG. Reason: Lack of Sterility Assurance: Aseptic process simulation failure..
Details
Source
Drug Recall
External ID
D-0262-2024
Action Date
2024-01-31
Status
Terminated
Category
drug
Product Description
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Lot/Code Info: lot #13D012AA, Exp: 08/31/2025
Quantity Affected: 22,176 Vials
Reason for Recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-10
Company
Zug, N/A
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 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
BE PHARMACEUTICALS AG has 2 FDA actions in our database, including 2 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 (BE PHARMACEUTICALS AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BE PHARMACEUTICALS AG have FDA actions?
BE PHARMACEUTICALS AG has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0262-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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