PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: September 25, 2019 Initiated: August 23, 2019 #D-1865-2019

Product Description

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

Details

Recalling Firm
Aurolife Pharma, LLC
Units Affected
a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons
Distribution
Nationwide in the USA
Location
Dayton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Aurolife Pharma, LLC. Units affected: a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on September 25, 2019. Severity: Moderate. Recall number: D-1865-2019.