Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBU...

FDA Recall #D-0617-2022 — Class II — October 26, 2021

Recall #D-0617-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

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

7,632 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1BK0826, Exp 12/31/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated