Oxymetazoline Hydrochloride Spray
FDA Recall NDC 63868-607
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 Oxymetazoline Hydrochloride (NDC 63868-607). A significant event, classified as Class II, was initiated on Dec 28, 2023 by Chain Drug Marketing Association Inc.. The reported reason for this action was: "CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Dec 28, 2023
Jan 10, 2024
7,992 bottles
Recall Profile & Regulatory Data
Event ID
93708
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Seaway Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MI, PA
Product Description
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 63868-607-01, UPC 6-35515-98843-9, b) Premier Value, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne, PA 19087 UPC 8-40986-03509-8.
Batch or Lot Expiration Information
Lot# SD23032, Exp 04/30/2026
Affected Packages Involved in this Recall
63868-607-01Product
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.
