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Recall Observatory FDA recall evidence

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

April 24, 2018

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
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

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations