Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-coun
Recalled February 27, 2019 · FDA recall D-0506-2019 · Mylan Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing · FDA Class III
Units
8,159 bottles
Sold at
Throughout the United States
Description
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Product
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →