Home / Recalls / Aurolife Pharma, LLC / D-1865-2019

D-1865-2019 Class II Terminated

Recalled by Aurolife Pharma, LLC — Dayton, NJ

Recall Details

Product Type
Drugs
Report Date
September 25, 2019
Initiation Date
August 23, 2019
Termination Date
August 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons

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

Distribution Pattern

Nationwide in the USA

Code Information

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

Other recalls by Aurolife Pharma, LLC

  • D-0877-2023 Class III — Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: A (May 18, 2023)
  • D-0087-2023 Class II — Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobin (December 16, 2022)
  • D-0736-2022 Class II — Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Au (March 17, 2022)
  • D-1874-2019 Class II — Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISC (August 23, 2019)
  • D-1867-2019 Class II — fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, (August 23, 2019)
  • D-1871-2019 Class II — Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Auroh (August 23, 2019)
  • D-1869-2019 Class II — Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, (August 23, 2019)
  • D-1872-2019 Class II — Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Dist (August 23, 2019)
  • D-1870-2019 Class II — Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (August 23, 2019)
  • D-1864-2019 Class II — Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed b (August 23, 2019)