Drug product
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
D-0819-2018
Product summary
- Event
- Event 79957
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,488 bottles
- Official record key
drug-enforcement:D-0819-2018
Official wording
Reason: cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Code information: Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019
Distribution pattern: Product was distributed throughout United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations