FDAFDA · Food and drugs·Recall number D-0216-2024
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MI 48375, NDC# 63868-676-01, UPC 6-35515-98847-7.
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
- 0635515988439
- Lot
- Lot # SE23034, Exp 05/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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