Recalls / Class II
Class IID-0214-2024
Product
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.
- Brand name
- Oxymetazoline Hydrochloride
- Generic name
- Oxymetazoline Hydrochloride
- Active ingredient
- Oxymetazoline Hydrochloride
- Route
- Nasal
- NDC
- 63868-607
- FDA application
- M012
- Affected lot / code info
- Lot # SD23032, Exp 04/30/2026
Why it was recalled
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.
Recalling firm
- Firm
- Seaway Pharma Inc.
- Manufacturer
- CHAIN DRUG MARKETING ASSOCIATION INC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5 County Route 42, N/A, Massena, New York 13662-1569
Distribution
- Quantity
- 7,992 bottles
- Distribution pattern
- MI, PA
Timeline
- Recall initiated
- 2023-12-28
- FDA classified
- 2024-01-04
- Posted by FDA
- 2024-01-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0214-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.