Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown

Recalled September 3, 2014 · FDA recall D-1557-2014 · Mylan Pharmaceuticals

Hazard

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. · FDA Class III

Units

2,658 Bottles

Sold at

Nationwide

Description

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Product

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.

Manufacturer(s)

Mylan Pharmaceuticals Inc.

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