Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 H...
FDA Recall #D-0216-2024 — Class II — December 28, 2023
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.
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.
Recalling Firm
Seaway Pharma Inc. — Massena, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,992 bottles
Distribution
MI, PA
Code Information
Lot # SE23034, Exp 05/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated