Drug product
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.
D-0242-2026
Product summary
- Event
- Event 98113
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 845 kits
- Official record key
drug-enforcement:D-0242-2026
Official wording
Reason: Presence of particulate matter: potential presence of metal particulates in the product.
Code information: Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
particulate matter