December 10, 2020
The failure of a single lot to pass routine stability testing has prompted InvaTech Pharma Solutions to recall three lots of levocetirizine dihydrochloride tablets distributed throughout the United States by Marlex Pharmaceuticals. The recall was included in the December 9, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count bottles of levocetirizine dihydrochloride tablets, 5 mg (NDC 10135-0639-30), from lots 051944A (Exp. 4/21), 1119124 (Exp. 10/21), and 062088 (Exp. 6/22).
InvaTech Pharma Solutions voluntarily initiated the recall November 11, 2020. The FDA designated the recall Class III on December 3, 2020. Under the recall classification, use of the affected tablets is not likely to cause harm.
Levocetirizine dihydrochloride is a prescription antihistamine used to treat hay fever and hives.