Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only ...

FDA Drug Recall #D-0262-2024 — Class II — January 10, 2024

Recall Summary

Recall Number D-0262-2024
Classification Class II — Moderate risk
Date Initiated January 10, 2024
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm BE PHARMACEUTICALS AG
Location Zug, N/A
Product Type Drugs
Quantity 22,176 Vials

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.

Reason for Recall

Lack of Sterility Assurance: Aseptic process simulation failure.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

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

Other Recalls from BE PHARMACEUTICALS AG

Recall # Classification Product Date
D-1148-2023 Class II Pantoprazole Sodium for Injection 40mg per vial... Sep 5, 2023

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.