Merck Emend
Presence of particulate matter: potential presence of metal particulates in the product.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Noxafil posaconazole NDC 00085-2224 |
300 mg/1 | Powder, for Suspension Oral |
Merck Sharp & Dohme LLC | Rx |
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.
Presence of particulate matter: potential presence of metal particulates in the product.
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Presence of Particulate Matter: Identified as Glass Particles
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.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of Particulate Matter: Hair was found in a prefilled syringe
Presence of particulate matter - Glass like particles.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.