FDAClass IIJanuary 31, 2024

Fosaprepitant for Injection 150 mg per vial recall: Sterility Concern

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.

Why was Fosaprepitant for Injection 150 mg per vial recalled?

Lack of Sterility Assurance: Aseptic process simulation failure.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot #13D012AA, Exp: 08/31/2025

Product
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.
Recalling firm
BE PHARMACEUTICALS AG
Quantity
22,176 Vials
Distribution
Nationwide in the USA
Recall date
January 31, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls