FDAFDA · Food and drugs·Recall number D-0214-2024
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.
Published January 10, 2024 · Recall initiated: December 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OXYMETAZOLINE HYDROCHLORIDE
- Manufacturer
- Seaway Pharma Inc.
- Distributor
- MI, PA
- UPC
- 0635515988446
- Lot
- Lot # SD23032, Exp 04/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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