Home / Recalls / Seaway Pharma Inc. / D-0216-2024

D-0216-2024 Class II Ongoing

Recalled by Seaway Pharma Inc. — Massena, NY

Recall Details

Product Type: Drugs
Report Date: January 10, 2024
Initiation Date: December 28, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,992 bottles

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.

Distribution Pattern

MI, PA

Code Information

Lot # SE23034, Exp 05/31/2026