Prescription pyridostigmine bromide oral solution recalled for out-of-specification preservative
VistaPharm recalls 1980 unit-dose cups of pyridostigmine bromide oral solution due to a preservative ingredient found out of specification during quality control. Lot 832400, nationwide distribution.
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: This is an FDA Class II recall due to a cGMP manufacturing deviation with a preservative ingredient out of specification. The source reports no illnesses, injuries, or confirmed adverse events, making the hazard theoretical and precautionary. Class II recalls without reported harm warrant Moderate severity.
Plain-English summary
VistaPharm, Inc. is recalling Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL in unit-dose cups. The recall involves lot 832400 (expiration 08/2023) and affects 1980 cups identified by NDC 66689-406-01, distributed nationwide.
The recall was initiated due to a current Good Manufacturing Practice (cGMP) deviation. Quality control testing found that a preservative ingredient was out of specification for assay. Preservatives are critical to maintaining product sterility and preventing microbial contamination.
Patients with questions about this medication should contact their pharmacist or healthcare provider. Patients should not discontinue their medication without consulting their physician. Healthcare providers or patients seeking more information can contact VistaPharm, Inc. or the FDA.
The recalled product
- Product
- PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE)
- Brand
- PYRIDOSTIGMINE BROMIDE
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug
- Affected units
- 1,980
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#: 832400
- Exp 08/2023
Distribution
Distributed nationwide across the United States.
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