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.

Recall Number: D-0428-2019

Firm: Mylan Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20190206

Initiation Date: 20190118

Termination Date: 20191009

Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.

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.