Drug recall D-1865-2019

Class II Terminated reported Sep 25, 2019

Product

Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.

Reason for recall

Failed Impurities/Degradation Specifications

Lots and codes

Lot #s: a) 067180025D1, Exp 07/21; b) 067180025B1, Exp 07/21; c) 067180025A1, Exp 07/21; d) 067180025C1, Exp 07/21

Recall details

Recalling firm
Aurolife Pharma, LLC, Dayton, NJ
Quantity
a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
August 23, 2019
Terminated
August 16, 2022