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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Quality Choice and Premier Value Nasal Sprays and Tussin Recalled for Contamination

Agency Publication Date: January 4, 2024
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Summary

Seaway Pharma Inc. is recalling approximately 28,320 bottles of Quality Choice and Premier Value brand nasal sprays and Premier Value Tussin Cough DM. The recall was issued due to possible microbial contamination in the purified water used during the manufacturing process, which was discovered during quality control deviations. While testing did not find contamination in the finished products themselves, the firm is removing the items from the market as a precaution. The affected medications were distributed to retailers in Michigan and Pennsylvania.

Risk

If the products were contaminated with bacteria, they could cause infections, particularly for individuals with compromised immune systems. No injuries or illnesses have been reported to date in connection with this recall.

What You Should Do

  1. This recall affects Quality Choice and Premier Value brand nasal sprays (Oxymetazoline HCl) and Premier Value Tussin Cough DM (Dextromethorphan HBr and Guaifenesin) with lot numbers SD23032, SD23033, SE23034, and SE23035.
  2. Identify the affected products by checking the lot number and expiration date printed on the bottle; affected expiration dates range from April 2025 to May 2026.
  3. If you have health concerns, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Seaway Pharma Inc. directly for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution (1 fl. oz.)
Variants: Quality Choice, Premier Value, 12 Hour Pump Mist
UPC Codes:
635515988439
840986035098
Lot Numbers:
SD23032 (Exp 04/30/2026)
NDC:
63868-607-01

Distributed by C.D.M.A. Inc. and Pharmacy Value Alliance, LLC.

Product: Premier Value Tussin Cough DM (8 fl. oz.)
Variants: Alcohol Free, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant
UPC Codes:
840986037894
Lot Numbers:
SD23033 (Exp 04/30/2025)

Distributed by Pharmacy Value Alliance, LLC.

Product: Quality Choice No Drip Extra Moisturizing Nasal Pump Mist (1 fl. oz.)
Variants: Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant
UPC Codes:
635515988477
Lot Numbers:
SE23034 (Exp 05/31/2026)
NDC:
63868-676-01

Distributed by C.D.M.A. Inc.

Product: Quality Choice No Drip Severe Congestion Nasal Pump Mist (1 fl. oz.)
Variants: Oxymetazoline hydrochloride 0.05%, 12 Hours
UPC Codes:
635515988460
Lot Numbers:
SE23035 (Exp 05/31/2026)
NDC:
63868-608-01

Distributed by C.D.M.A. Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93708
Status: Active
Manufacturer: Seaway Pharma Inc.
Sold By: C.D.M.A. Inc.; Pharmacy Value Alliance, LLC
Manufactured In: United States
Units Affected: 4 products (7,992 bottles; 4,176 bottles; 7,992 bottles; 8,160 bottles)
Distributed To: Michigan, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.