X-Gen Recalls Neomycin Sulfate Tablets Due to Microbiological Failure
X-Gen Pharmaceuticals is recalling Neomycin Sulfate Tablets 500mg because a microbiological assay failed to meet stability specifications.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling Neomycin Sulfate Tablets, USP 500mg, which are prescription-only medications. The affected product is packaged in 10x10 unit dose blister strips containing 100 tablets each. The specific lot number is CFMBX with an expiration date of 9/2022.
The recall was initiated because an out-of-specification (OOS) result was reported for a microbiological assay, indicating that the product failed to meet stability specifications. This suggests potential issues with the microbial quality of the tablets.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected lot and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
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 # CFMBX
- EXP 9/2022
Distribution
Distributed nationwide across the United States.
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