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.

1–25 of 30

  • ModerateFDA (Drugs)··2022-01-12

    Wal-Fex Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers distributed nationwide.

    Product
    Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Perrigo Fexofenadine Hydrochloride 180mg tablets recalled for impurity

    Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 containers distributed nationwide.

    Product
    Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Perrigo basic+care Fexofenadine Tablets Recall—Failed Impurity Specifications

    Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets (180 mg, 150-count bottles) distributed nationwide because impurity testing results exceeded specification limits during stability testing.

    Product
    basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    GoodSense Aller.Ease fexofenadine tablets recalled for impurity specification failure

    Perrigo Company PLC is recalling GoodSense Aller.Ease fexofenadine hydrochloride 60 mg tablets nationwide due to failed impurity and degradation specifications identified during stability testing.

    Product
    GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010.
    Category
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    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 02
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Perrigo Fexofenadine Hydrochloride Tablets Recall for Impurity Contamination

    Perrigo Company PLC is recalling Fexofenadine Hydrochloride 60mg antihistamine tablets (100-count bottles) nationwide due to failed impurity specifications found during stability testing. The recall affects 41,472 containers distributed in the USA.

    Product
    Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2
    Category
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Kroger Allergy Relief Fexofenadine Tablets Recalled for Impurity

    Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.

    Product
    Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Health Mart Fexofenadine Hydrochloride 180mg Tablets Recall

    Perrigo Company is recalling Health Mart Fexofenadine Hydrochloride 180mg antihistamine tablets due to failed impurity specifications detected during stability testing. The recall affects approximately 6,960 containers distributed nationwide.

    Product
    Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Up&Up Allergy Relief 180mg Tablets Recalled for Failed Impurity Specification

    Perrigo Company PLC is recalling up&up allergy relief fexofenadine hydrochloride 180mg tablets distributed nationwide because stability testing found impurity A exceeded specifications. The affected products are 15-count and 30-count bottles with specific lot numbers and expiration dates.

    Product
    up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Re
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    H.E.B Allergy Relief Fexofenadine tablets recalled for impurity specification failure

    Perrigo Company is recalling H.E.B Allergy Relief fexofenadine hydrochloride 60mg tablets nationwide due to failure of impurity specifications during stability testing.

    Product
    H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    H.E.B Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications

    H.E.B Allergy Relief fexofenadine hydrochloride tablets (180mg) are being recalled nationwide due to out-of-specification results for impurity A found during stability testing. The affected product is available in 15, 30, and 45 count bottles.

    Product
    H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Ma
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    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
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    DG/health Aller.Ease Fexofenadine Tablets Recalled for Impurity

    Perrigo Company PLC is recalling DG/health Aller.Ease Fexofenadine Hydrochloride 180 mg tablets nationwide because they failed impurity specifications during stability testing.

    Product
    DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7
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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
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    GoodSense Aller.Ease Fexofenadine Recalled for Impurity Specification

    Perrigo Company PLC is recalling GoodSense Aller.Ease Fexofenadine hydrochloride 180 mg tablets nationwide due to an out-of-specification impurity detected during stability testing.

    Product
    GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30,
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Berkley Jensen Fexofenadine Tablets Recalled for Impurity Specification Failure

    Perrigo Company PLC is recalling Berkley Jensen Allergy Relief 180 mg fexofenadine tablets due to an impurity specification failure detected during stability testing. The recall affects 7,670 containers distributed nationwide.

    Product
    berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity Specifications

    Perrigo Company is recalling CVS Allergy Relief Fexofenadine Hydrochloride 180 mg tablets due to an out-of-specification impurity result found during stability testing. The recall affects one lot distributed nationwide.

    Product
    CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Meijer Fexofenadine Hydrochloride Allergy Relief Tablets Recalled

    Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.

    Product
    Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Rite Aid Allergy Relief Fexofenadine Tablets Recalled for Impurity

    Rite Aid Allergy Relief Fexofenadine Hydrochloride 60mg tablets are being recalled due to failed impurity specifications detected during stability testing. The affected product was distributed nationwide.

    Product
    Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
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    0 states
  • 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
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    TopCare Allergy Relief Fexofenadine tablets recalled for impurity specification failure

    Perrigo Company PLC is recalling TopCare Allergy Relief Fexofenadine Hydrochloride 60mg tablets (12-count bottles, Lot #0LE2178) distributed nationwide due to an out-of-specification impurity result found during stability testing.

    Product
    TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
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    0 states
  • ModerateFDA (Drugs)··2022-01-12

    Fexofenadine Hydrochloride Tablets Recall for Failed Impurity Specifications

    Perrigo Company PLC is recalling basic+care allergy Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, due to out-of-specification impurity levels detected during stability testing.

    Product
    basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 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

    EQUALINE Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Testing

    Perrigo Company is recalling EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, due to impurity A exceeding specification limits during stability testing. The recalled products were distributed nationwide.

    Product
    EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
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    0 states