Equaline Nasal Spray
FDA Recall NDC 41163-343
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Equaline Nasal (NDC 41163-343). A significant event, classified as Class II, was initiated on Oct 26, 2021 by United Natural Foods, Inc. Dba Unfi. The reported reason for this action was: "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Oct 26, 2021
Mar 02, 2022
2,664 bottles
Recall Profile & Regulatory Data
Event ID
88905
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Perrigo Company PLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 29, 2023
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
Batch or Lot Expiration Information
Batch# Batch: 1FK1251, Exp 02/28/2023
Affected Packages Involved in this Recall
41163-343-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
