Drug product
Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
D-1192-2018
Product summary
- Event
- Event 80963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 bottles
- Official record key
drug-enforcement:D-1192-2018
Official wording
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Code information: Lot: 091515C, Exp 09/2018; 050118S, Exp 05/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination