Drug product
DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
D-0037-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 786,720 bottles
- Official record key
drug-enforcement:D-0037-2019
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