D-0607-2022 Class II Terminated

Recalled by Perrigo Company PLC — Allegan, MI

Recall Details

Product Type
Drugs
Report Date
March 2, 2022
Initiation Date
October 26, 2021
Termination Date
September 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,192 bottles

Product Description

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Batch: 1BK0716; Exp 12/31/2022); 1FK1251, Exp 02/28/2023