Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL)...

FDA Recall #D-0621-2022 — Class II — October 26, 2021

Recall #D-0621-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1

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

15,264 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1BK0964, Exp 01/31/2023; 1FK1164, Exp 01/31/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated