FDAFDA · Food and drugs·Recall number D-0819-2018
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Published May 23, 2018 · Recall initiated: April 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout United States
- Lot
- Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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