Drug product
Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
D-0044-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8592 bottles
- Official record key
drug-enforcement:D-0044-2019
Official wording
Reason: CGMP Deviations: products manufactured under conditions that could impact its product quality.
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations