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

FDA Recall #D-0611-2022 — Class II — October 26, 2021

Recall #D-0611-2022 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, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10

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

89,208 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1BK0912, Exp 12/31/2022; 1FK1251, Exp 02/28/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated