US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 24, 2018 (8 years ago)

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure

What was recalled

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

Recalling firm
Mylan Pharmaceuticals Inc.
NDC code
0378-6896-01
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0819-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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