Topical antifungal Nyamyc recalled due to storage temperature deviations
Cardinal Healthcare is recalling Nyamyc topical antifungal medication (Batch 400454) nationwide due to exposure to temperatures outside labeled storage conditions.
What this means for you
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: FDA Class II recall for manufacturing process deviation (temperature exposure outside labeled conditions). No illnesses or injuries reported; the hazard is theoretical (potential reduced drug efficacy or integrity). Score reflects manufacturing deviation classification with absent adverse events.
Plain-English summary
Nyamyc, a prescription topical antifungal medication containing 100,000 USP units per gram in 60-gram containers, is being recalled by Cardinal Healthcare. The product is manufactured by Upsher-Smith Laboratories, Inc. (Minneapolis, MN).
The recall was initiated because products in Batch 400454 were exposed to temperatures outside the labeled storage conditions. This deviation from good manufacturing practice (CGMP) may affect the stability and efficacy of the medication.
The affected products were distributed nationwide. Healthcare facilities and pharmacies in the United States may have received affected units.
Patients and healthcare providers with Nyamyc from Batch 400454 should discontinue use and contact their pharmacy or supplier for instructions. Patients should consult their healthcare provider about alternative treatment options while the recall is resolved.
The recalled product
- Product
- Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Topical / Antifungal
- Hazard
- improper-storage
- stability-compromise
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 (1)
- Batch 400454
Distribution
Distributed nationwide across the United States.
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