Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per...

FDA Recall #D-0610-2022 — Class II — October 26, 2021

Recall #D-0610-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10

Reason for Recall

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Recalling Firm

Perrigo Company PLC — Allegan, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,664 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1FK1251, Exp 02/28/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated