VistaPharm Recalls Nystatin Oral Suspension Due to Impurity
VistaPharm is recalling Nystatin Oral Suspension because one lot failed impurity specifications. The affected product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a chemical impurity in a single lot.
Plain-English summary
VistaPharm, Inc. is recalling Nystatin Oral Suspension, USP 100,000 units per mL (Bubblegum Flavored), 16 fl. oz. bottles. The recall involves 14,244 bottles from Lot 638800 with an expiration date of 10/21. The product was distributed nationwide in the USA, including Puerto Rico.
The recall was initiated because the product failed impurity/degradation specifications, specifically due to out-of-specification results for an impurity in one lot. The agency has classified this recall as Class III.
Consumers should check their inventory for the specific lot number and expiration date listed above. If they have the affected product, they should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Antifungal
- Hazard
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)
- Lots: 638800 Exp 10/21
Distribution
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