Drug product
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
D-1236-2020
Product summary
- Event
- Event 85183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2101 units
- Official record key
drug-enforcement:D-1236-2020
Official wording
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information: Lot #: 105180004A, Exp. Date 03/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations