Mylan Pharmaceuticals Inc. recalls Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b)

Recalled November 13, 2013 · FDA recall D-66403-006 · Mylan Pharmaceuticals

Hazard

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. · FDA Class II

Units

30,878 bottles

Sold at

Nationwide and Puerto Rico

Description

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Product

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Manufacturer(s)

Mylan Pharmaceuticals Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →