Drug product
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
D-0054-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,488 tubes
- Official record key
drug-enforcement:D-0054-2019
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