Class II · Moderate risk
Merck Emend
Presence of particulate matter: potential presence of metal particulates in the product.
Fosaprepitant for Injection 150 mg per vial
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance: Aseptic process simulation failure.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
71839-0104-01
Compare with the code on your package — it is the most precise check available.
Drug: Aprepitant
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| fosaprepitant NDC 71839-0104 |
DIMEGLUMINE 150 mg/5mL | Injection, Powder, Lyophilized, for Solution Intravenous |
BE Pharmaceuticals Inc. | Rx |
- Recalling firm
- Be Pharmaceuticals Ag
- NDC code
- 71839-104-01
- Origin
- N/A, Switzerland
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0262-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Aprepitant recalls
See all
Class II · Moderate risk
Aprepitant Capsule
cGMP deviations: Temperature abuse
Class III · Low risk
Aprepitant Capsules
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class II · Moderate risk
Aprepitant active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Be Pharmaceuticals Ag
All 2024 recalls
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Other sterility / contamination recalls from 2024
All sterility / contamination recalls
Class II · Moderate risk
phenylephrine in 0.9% Sodium Chloride Inj
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk
ketamine inj 50 mg per 1 mL
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class II · Moderate risk
PROFESSIONAL Regener-Eyes
Lack of Sterility Assurance
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