FDAFDA · Food and drugs·Recall number D-0217-2024
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MI 48375, NDC 63868-608-01, UPC 6-35515-98846-0
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
- 635515988460
- Lot
- Lot # SE23035, Exp 05/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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