Drug product
SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1
D-0114-2019
Product summary
- Firm
- Sprayology
- Event
- Event 81218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,393 bottles
- Official record key
drug-enforcement:D-0114-2019
Official wording
Reason: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Code information: All lots within expiry
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
microbial contamination