X-Gen Recalls Nystatin Topical Powder Due to Potential Plastic Particles
X-Gen Pharmaceuticals is recalling Nystatin Topical Powder due to the potential presence of plastic particles. The recall covers 9,816 bottles distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is the potential presence of foreign plastic particles, which is a significant quality issue but does not meet the criteria for Critical or Severe severity in the absence of reported injuries or deaths.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61. The recall is being conducted due to the potential presence of plastic particles in the product.
The affected product is identified by Lot # 23701.158A with an expiration date of 10/31/18. A total of 9,816 bottles were distributed nationwide in the US.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 9,816
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 (2)
- Lot #: 23701.158A
- EXP 10/31/18
Distribution
Distributed nationwide across the United States.
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