Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class II · Moderate risk Terminated Jul 27, 2021

Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC…

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

Perrigo Company PLC NDC 41250-060-22 D-0343-2022

Class II · Moderate risk Terminated Jul 27, 2021

MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals…

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

Perrigo Company PLC NDC 0904-6979-60 D-0342-2022

Class II · Moderate risk Terminated Jul 27, 2021

Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger…

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

Perrigo Company PLC NDC 30142-555-53 D-0341-2022

Class II · Moderate risk Terminated Jul 27, 2021

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC…

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

Perrigo Company PLC NDC 37808-571-22 D-0340-2022

Class II · Moderate risk Terminated Jul 27, 2021

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care…

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

Perrigo Company PLC NDC 37808-425-53 D-0339-2022

Class II · Moderate risk Terminated Jul 27, 2021

Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555…

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

Perrigo Company PLC NDC 62011-0233-1 D-0338-2022

Class II · Moderate risk Terminated Jul 27, 2021

Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555…

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

Perrigo Company PLC NDC 62011-0413-1 D-0337-2022

Class II · Moderate risk Terminated Jul 27, 2021

DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in…

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

Perrigo Company PLC D-0336-2022

Class II · Moderate risk Terminated Jul 27, 2021

CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC…

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

Perrigo Company PLC NDC 59779-425-53 D-0335-2022

Class II · Moderate risk Terminated Jul 27, 2021

CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC…

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

Perrigo Company PLC NDC 41520-229-39 D-0334-2022

Class II · Moderate risk Terminated Jul 27, 2021

berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the…

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

Perrigo Company PLC D-0333-2022

Class II · Moderate risk Terminated Jul 27, 2021

basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic…

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

Perrigo Company PLC NDC 0113-7425-78 D-0332-2022

Class II · Moderate risk Terminated Jul 27, 2021

basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech…

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

Perrigo Company PLC NDC 0113-7571-47 D-0331-2022

Class II · Moderate risk Terminated Jul 27, 2021

amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic…

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

Perrigo Company PLC D-0330-2022

Class II · Moderate risk Terminated Jul 27, 2021

GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech…

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

Perrigo Company PLC D-0329-2022

Class II · Moderate risk Terminated Jul 27, 2021

EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0…

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

Perrigo Company PLC NDC 41163-571-22 D-0328-2022

Class II · Moderate risk Terminated Mar 15, 2021

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 60432-275-16 D-0596-2021

Class II · Moderate risk Terminated Mar 15, 2021

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 51672-2131-8 D-0572-2021

Class II · Moderate risk Terminated Mar 15, 2021

Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0548-2021

Class II · Moderate risk Terminated Mar 15, 2021

LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0547-2021

Class II · Moderate risk Terminated Mar 15, 2021

Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 45802-571-78 D-0546-2021

Class II · Moderate risk Terminated Mar 15, 2021

Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0904-5306-60 D-0512-2021

Class II · Moderate risk Terminated Mar 15, 2021

Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0173-0887-10 D-0482-2021

Class II · Moderate risk Terminated Mar 15, 2021

TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0481-2021

Class II · Moderate risk Terminated Mar 15, 2021

Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only…

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0173-0876-10 D-0480-2021

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