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

FDA recall notice · announced May 23, 2018 · Mylan Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Product was distributed throughout United States
Lot/code information: Lot Numbers# 3083008 and 3086124, exp Jan 2019
Quantity: 12,924 bottles
Status: Terminated
Products in this recall event:
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01 (D-0819-2018)
- Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01 (D-0820-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.