OTC Nasal Decongestant Recalled Due to Manufacturing Process Deviation
Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.
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: This is a FDA Class II voluntary precautionary recall based on a manufacturing deviation with no contamination detected in finished products and no reported illnesses or injuries.
Plain-English summary
Seaway Pharma Inc. is recalling Quality Choice No Drip Extra Moisturizing Nasal Pump Mist (Oxymetazoline hydrochloride 0.05%) due to a manufacturing deviation. The firm reported possible microbial contamination in the purified water used during manufacturing. However, no contamination was found in any of the finished products.
The recall affects 7,992 bottles of Lot SE23034 with expiration date 05/31/2026, distributed in Michigan and Pennsylvania. The affected product is 1 fl oz (30 mL) bottles with NDC# 63868-676-01 and UPC 6-35515-98847-7.
Consumers who have this product should not use it and should contact their pharmacy, healthcare provider, or distributor for instructions on return or disposal.
The recalled product
- Product
- OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- OXYMETAZOLINE HYDROCHLORIDE
- Manufacturer
- Seaway Pharma Inc.
- Category
- Drug — OTC Nasal Decongestant
- Hazard
- Affected units
- 7,992
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 # SE23034
- Exp 05/31/2026
UPCs (3)
- 0635515988439
- 0635515988477
- 635515988477
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.
See all 4 products in this recall →Related recalls
Same brand · OXYMETAZOLINE HYDROCHLORIDE
- ModerateOxymetazoline Nasal Spray Recalled Due to Manufacturing Process Deviation
FDA (Drugs) · 2024-01-10
- ModerateNasal Decongestant Recalled for Possible Manufacturing Water Contamination
FDA (Drugs) · 2024-01-10
Same manufacturer · Seaway Pharma Inc.
See all →- ModerateOTC Cough Medicine Recalled for Potential Water Contamination Risk
FDA (Drugs) · 2024-01-10
Same hazard · microbial contamination
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