The Recall Desk
ModerateFDA (Drugs)·D-0215-2024·Announced 2024-01-10

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.

What this means for you

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
  • microbial-contamination

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

Distributed in 2 states:

  • MI
  • PA