Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-522
Recalled November 30, 2016 · FDA recall D-0151-2017 · Mylan Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: OOS results for known compound. · FDA Class III
Units
51,983 extended release capsules
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: OOS results for known compound.
Product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →