Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC
Recalled February 6, 2019 · FDA recall D-0428-2019 · Mylan Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification. · FDA Class II
Units
88,090 bottles
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Product
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); 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 →