Status
Ongoing
Drug Enforcement D-0214-2024
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.
Classification
Class II
Report Date
January 10, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- 7,992 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- MI, PA
Location & Firm
- Recalling firm
- Seaway Pharma Inc.
- Address
-
5 County Route 42, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0214-2024
- Event ID
- 93708
- Recall initiation date
- December 28, 2023
- Center classification date
- January 4, 2024
- Code info
- Lot # SD23032, Exp 04/30/2026
- More code info
- —