Lohxa Recalls Bismuth Subsalicylate Suspension Due to Incorrect Expiration Date
Lohxa LLC is recalling Bismuth Subsalicylate Oral Suspension because the labels contain incorrect expiration dates. The affected product was distributed in Massachusetts, New York, and Wyoming.
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 due to a labeling error (incorrect expiration date). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported illness or injury are rated as Moderate (2).
Plain-English summary
Lohxa LLC is recalling Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, NDC 70166-059-01. The recall was initiated because the product labels contain an incorrect expiration date. The specific lot number is M030042P, and the incorrect expiration date listed is 01/2020.
The recalled product consists of 5 boxes containing 250 unit dose cups. Distribution was limited to Massachusetts, New York, and Wyoming.
Consumers who have this product should stop using it and contact Lohxa LLC for further instructions or a refund. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
- Manufacturer
- Lohxa LLC
- 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 (2)
- Lot#: M030042P
- Exp. 01/2020
Distribution
Part of a larger recall action
This product is one of 2 recalled by Lohxa LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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