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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