D-0043-2019 Class II Terminated

Recalled by Product Quest Manufacturing LLC — Daytona Beach, FL

Recall Details

Product Type
Drugs
Report Date
October 24, 2018
Initiation Date
August 3, 2018
Termination Date
March 30, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3264 bottles

Product Description

HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .

Reason for Recall

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Distribution Pattern

Nationwide in the USA

Code Information

All lots remaining within expiry.