Drug product
NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
D-0438-2023
Product summary
- Event
- Event 91708
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4004
- Official record key
drug-enforcement:D-0438-2023
Official wording
Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Code information: Lot: 222016, Exp: 01/25;
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations