Home / Recalls / Seaway Pharma Inc. / D-0214-2024

D-0214-2024 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

Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.

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 # SD23032, Exp 04/30/2026