OTC Cough Medicine Recalled for Potential Water Contamination Risk
Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.
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: FDA Class II recall with no contamination detected in finished products and no reported illnesses. This is a voluntary precautionary recall based on a manufacturing process deviation.
Plain-English summary
Seaway Pharma Inc. is recalling Premier Value Tussin Cough DM, an over-the-counter cough suppressant and expectorant, distributed in 8 FL OZ bottles. The affected product has lot number SD23033 with an expiration date of 04/30/2025 and was distributed in Michigan and Pennsylvania.
The firm reported a potential cGMP (Current Good Manufacturing Practice) deviation involving purified water used in the manufacturing process. No contamination was found in the final products; the firm initiated this recall as a precautionary measure.
Consumers who have purchased this product should discontinue use. The product can be returned to the point of purchase.
The recalled product
- Product
- Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
- Manufacturer
- Seaway Pharma Inc.
- Hazard
- Affected units
- 4,176
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 # SD23033
- Exp 04/30/2025
Distribution
Part of a larger recall action
This product is one of 4 recalled by Seaway Pharma Inc. 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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