Seaway Pharma Inc.: Drug Recall

Recall Details

Recall Number

D-0214-2024

Classification

Class II

Product Type

Drug

Recalling Firm

Seaway Pharma Inc.

Status

Ongoing

Date Initiated

12/28/2023

Location

Massena, NY, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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.

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.

Distribution Pattern

MI, PA

Other Recalls by Seaway Pharma Inc.

• Class II: Risk 12/28/2023
  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.
• Class II: Risk 12/28/2023
  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.
• Class II: Risk 12/28/2023
  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.

View all recalls by Seaway Pharma Inc. →