Posaconazole oral suspension recalled over potential metal particulates in the product
Merck Sharp & Dohme is recalling 845 kits of Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension over the potential presence of metal particulates.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: metal particulates in an oral medicine are a stated physical contaminant, and no injuries are reported.
Plain-English summary
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, manufactured by N.V. Organon of Oss, the Netherlands for Merck Sharp & Dohme LLC of Rahway, New Jersey, is being recalled.
The reason given in the enforcement record is the presence of particulate matter: the potential presence of metal particulates in the product.
The recall covers 845 kits from lots Z012339, Z010344, Z009908 and Z009909, all with an expiry date of 12-31-2026. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific kit is affected and arrange a replacement.
The recalled product
- Product
- NOXAFIL (POSACONAZOLE)
- Brand
- NOXAFIL
- Manufacturer
- Merck Sharp & Dohme LLC
- Category
- Drug — Antifungal
- Affected units
- 845
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot#: Z012339
- Z010344
- Z009908
- Z009909
- Exp Date 12-31-2026
UPCs (1)
- 0300854324025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Merck Sharp & Dohme LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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