Amlodipine and Benazapril HCL Capsules recall: CGMP Deviations
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Why was Amlodipine and Benazapril HCL Capsules recalled?
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers# 3083008 and 3086124, exp Jan 2019
- Product
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 12,924 bottles
- Distribution
- Product was distributed throughout United States
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)