The Recall Desk

FDA (Drugs) recall action 83581

Aurolife Pharma, LLC recalled 11 products on 2019-09-25

The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products
11
Announced
2019-09-25
Critical
0
Units
228,628

Why these products were recalled

Failed Impurities/Degradation Specifications

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

  • SevereFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 4,536 cartons of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling specific lots of Fexofenadine Hydrochloride 180 mg tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 8,240 bottles of Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Recalls Fexofenadine Tablets Due to Impurity Failures

    Aurolife Pharma is recalling equate Allergy Relief tablets because they failed impurity and degradation specifications.

    Product
    Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 71,748 bottles of Member's Mark fexofenadine hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
    Category
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    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Fexofenadine HCL Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 6,104 bottles of Fexofenadine HCL 180 mg tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 3,240 cartons of Allergy Relief (fexofenadine hydrochloride) tablets because they failed impurity and degradation specifications.

    Product
    Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Fexofenadine Hydrochloride Tablets for Impurity Failures

    Aurolife Pharma is recalling specific lots of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Wal-Fex Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 4,920 cartons of Wal-Fex (Fexofenadine Hydrochloride) 180 mg tablets nationwide because they failed impurity and degradation specifications.

    Product
    Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-09-25

    Aurolife Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Failures

    Aurolife Pharma is recalling 240 bottles of 180 mg Fexofenadine Hydrochloride tablets because they failed impurity and degradation specifications.

    Product
    Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-09-25

    Aurolife Pharma Recalls Allergy Relief Tablets Due to Impurity Failures

    Aurolife Pharma is recalling specific lots of Allergy Relief (Fexofenadine Hydrochloride) 180 mg tablets because they failed impurities and degradation specifications.

    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.
    Category
    Distribution
    0 states