Class II · Moderate risk
Aprepitant Capsule
cGMP deviations: Temperature abuse
Merck Emend (Aprepitant)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of particulate matter: potential presence of metal particulates in the product.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03
Affected NDC
0006-3066-03
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 |
|---|---|---|---|---|
| Emend aprepitant NDC 00006-3066 |
125 mg/1 | Powder, for Suspension Oral |
Merck Sharp & Dohme LLC | Rx |
- Recalling firm
- Merck Sharp & Dohme LLC
- NDC code
- 0006-3066-03
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0241-2026 · 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.
Other Aprepitant recalls
See all
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.
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Class II · Moderate risk
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Class II · Moderate risk
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Class I · High risk
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Class II · Moderate risk
Zerbaxa (ceftolozane and tazobactam)
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
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