Drug recall D-0428-2019

Class II Terminated reported Feb 6, 2019

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.

Reason for recall

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

Lots and codes

Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
88,090 bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 18, 2019
Terminated
October 9, 2019