Drug 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.
D-0214-2024
Product summary
- Event
- Event 93708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7,992 bottles
- Official record key
drug-enforcement:D-0214-2024
Official wording
Reason: 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.
Code information: Lot # SD23032, Exp 04/30/2026
Distribution pattern: MI, PA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination