The Recall Desk

FDA (Drugs) recall action 88384

Perrigo Company PLC recalled 30 products on 2022-01-12

The FDA (Drugs) publishes a recall like this one as 30 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 30 pages.

Products
30
Announced
2022-01-12
Critical
0
Units
1,002,556

Why these products were recalled

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

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.

26–30 of 30

  • ModerateFDA (Drugs)··2022-01-12

    Amazon Basic+Care Fexofenadine Tablets Recalled for Failed Impurity Specifications

    Amazon Basic+Care Allergy Fexofenadine Hydrochloride Tablets (60 mg, 100-count) are being recalled because impurity levels exceeded acceptable limits during stability testing. The recall affects 38,352 bottles distributed nationwide.

    Product
    amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-01-12

    TopCare Allergy Relief Fexofenadine tablets recalled for impurity specifications

    Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 180mg tablets in multiple pack sizes due to failed impurity specifications during stability testing. The affected lots were distributed nationwide.

    Product
    TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90…
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Health Mart Fexofenadine Tablets Recalled for Failed Impurity Specifications

    Perrigo Company PLC is recalling Health Mart Fexofenadine Hydrochloride 12HR 60mg tablets due to impurity A exceeding specification limits during stability testing. The recall affects 12,384 containers distributed nationwide.

    Product
    Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Amazon Allergy Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Specifications

    Amazon-branded Allergy Fexofenadine Hydrochloride Tablets 180 mg are being recalled because testing found an out-of-specification impurity during stability testing.

    Product
    amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity

    CVS Allergy Relief Fexofenadine Hydrochloride Tablets 60 mg are being recalled because stability testing found an out-of-specification result for impurity A. The recall affects approximately 138,144 containers distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI…
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    Distribution
    0 states