Equate Nasal Spray, Metered
FDA Recall NDC 49035-388
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 Equate Nasal (NDC 49035-388). A significant event, classified as Class II, was initiated on Oct 26, 2021 by Wal-mart Stores Inc. 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
178,128 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
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10
Batch or Lot Expiration Information
Batch# Batch: 1CK0897, 1FK1233, 1FK1232, Exp 01/31/2023
Affected Packages Involved in this Recall
49035-388-10Product
49035-388-00Product
49035-388-20Product
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.
