Drug & medication recalls Moderate risk

Amlodipine and Benazapril HCL Capsules recalled over manufacturing violations

Recall date
April 24, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV…
Recall number
D-0820-2018
FDA classification
Class II
Brand / firm
Mylan Pharmaceuticals Inc.
Sold / distributed
Product was distributed throughout United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

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