Drug product
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
D-0882-2023
Product summary
- Event
- Event 92453
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,956 bottles
- Official record key
drug-enforcement:D-0882-2023
Official wording
Reason: cGMP deviations
Code information: Lot # 2414, exp. date Sep-24
Distribution pattern: Product was distributed USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP deviations