D-0819-2018 Class II Terminated
FDA drug recall D-0819-2018 was initiated by Mylan Pharmaceuticals Inc. on Apr 24, 2018 and is designated Class II. Reason for recall: cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure The recall status is terminated (terminated Jun 20, 2019). Affected quantity: 25,488 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- Apr 24, 2018
- Termination Date
- Jun 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,488 bottles
Product Description
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Reason for Recall
cGMP Deviations; cleaning process 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# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0819-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026