Drug product
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
D-0256-2019
Product summary
- Event
- Event 81228
- Status
- Terminated
- Classification
- Class II
- Quantity
- 247 bottles
- Official record key
drug-enforcement:D-0256-2019
Official wording
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Code information: Lot K022216C
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination