CLASS II ONGOING Drug recall · Reported 10 Jan 2024 · FDA Enforcement Report
Premier Value Tussin Cough DM recalled by Seaway Pharma
Seaway Pharma is recalling Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, distributed in Michigan, Pennsylvania. The recall was initiated on 28 Dec 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0215-2024
- FDA event ID
- 93708
- Recalling firm
- Seaway Pharma, Massena, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Dec 2023
- FDA classified
- 4 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 28 Dec 2023 | Recall initiated by company | |
| 4 Jan 2024 | Classified by FDA | +7 days |
| 10 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
MI, PA
Questions about this recall
Why was it recalled?
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Which lots are affected?
Lot # SD23033, Exp 04/30/2025
Where was it sold?
MI, PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 93708This product is part of a recall event; the main page for the event is Quality Choice No Drip Extra Moisturizing Nasal Pump Mist recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Quality Choice No Drip Extra Moisturizing Nasal Pump Mist recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA | |
| CLASS II | Nasal Spray Original No Drip Oxymetazoline HCl Nasal recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA | |
| CLASS II | Quality Choice No Drip Severe Congestion Nasal Pump Mist recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |
More recalls from Seaway Pharma
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Quality Choice No Drip Severe Congestion Nasal Pump Mist recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |
| Drug | CLASS II | Nasal Spray Original No Drip Oxymetazoline HCl Nasal recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |
| Drug | CLASS II | Quality Choice No Drip Extra Moisturizing Nasal Pump Mist recalledOxymetazoline Hydrochloride | Seaway Pharma | Sterility | MI, PA |