D-0820-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- April 24, 2018
- Termination Date
- June 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,924 bottles
Product Description
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Reason for Recall
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Distribution Pattern
Product was distributed throughout United States
Code Information
Lot Numbers# 3083008 and 3086124, exp Jan 2019