Reported May 23, 2018 · Terminated
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
- Lot codes and dates
Lot Numbers# 3083008 and 3086124exp Jan 2019
- Amount recalled
- 12,924 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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