May 24, 2018
Mylan Pharmaceuticals Inc. is recalling several lots of amlodipine and benazepril HCL capsules, USP, after discovering equipment used in manufacturing was not cleaned appropriately, according to the May 23, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 100-count bottles of:
- amlodipine and benazepril HCL capsules, 5 mg/40 mg (NDC 0378-6899-01) from lots 3083008 and 3086124 (Exp. 1/19), and
- amlodipine and benazepril HCL capsules, 5 mg/10 mg (NDC 0378-6896-01) from lots 3083005, 3083006, 3086121, and 3086122 (Exp. 1/19).
The recall affects more than 38,000 bottles distributed throughout the United States.
Mylan Pharmaceuticals voluntarily issued the recall April 24, 2018. The FDA designated it a Class II recall May 17, 2018. The classification communicates use of the tablets could cause temporary or medically reversible adverse health consequences. The probability of serious harm is remote.
Amlodipine and benazepril HCL capsules are used to treat high blood pressure.
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