Drug Enforcement D-0262-2024

Lack of Sterility Assurance: Aseptic process simulation failure.

Status

Terminated

Classification

Class II

Report Date

January 31, 2024

Termination Date

June 10, 2025

Product Information

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.
Product quantity
22,176 Vials
Reason for recall
Lack of Sterility Assurance: Aseptic process simulation failure.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
BE PHARMACEUTICALS AG
Address
Bundesstrasse 3, N/A

Switzerland
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0262-2024
Event ID
93747
Recall initiation date
January 10, 2024
Center classification date
January 25, 2024
Code info
lot #13D012AA, Exp: 08/31/2025
More code info
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