Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant,
Summary
The FDA issued a Class II for Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochl by Seaway Pharma Inc.. Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was .
Details
Source
Drug Recall
External ID
D-0216-2024
Action Date
2024-01-10
Status
Ongoing
Category
drug
Product Description
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
Lot/Code Info: Lot # SE23034, Exp 05/31/2026
Quantity Affected: 7,992 bottles
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.
Distribution
MI, PA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-28
Company
Massena, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 72 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Seaway Pharma Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Seaway Pharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Seaway Pharma Inc. have FDA actions?
Seaway Pharma Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0216-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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