XYZAL ALLERGY 24HR

Generic: LEVOCETIRIZINE DIHYDROCHLORIDE

ChattemManufacturer
ORALRoute
LEVOCETIRIZINE DIHYDROCHLORIDEActive Substance
2017-01-31Original Approval

XYZAL ALLERGY 24HR is FDA application NDA209089, sponsored by CHATTEM SANOFI. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2023-02-09
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-cou

Failed Impurities/Degradation Specifications

Class III2015-07-28
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 L

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Class II2020-03-16
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning informat

Class II2023-02-09
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-

Failed Impurities/Degradation Specifications

Class II2018-10-19
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was d

Class II2023-02-09
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-coun

Failed Impurities/Degradation Specifications

Class II2023-02-09
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, S

Failed Impurities/Degradation Specifications

Class II2021-07-27
CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle,

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A du

Class III2021-11-12
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Rele

Failed dissolution specifications

Class III2015-09-28
Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand d

Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester

Top Reported Reactions

1
DRUG INEFFECTIVE
43,659 reports
2
FATIGUE
28,276 reports
3
HEADACHE
22,267 reports
4
OFF LABEL USE
22,266 reports
5
PAIN
22,224 reports
6
NAUSEA
21,079 reports
7
DYSPNOEA
19,914 reports
8
DIARRHOEA
17,403 reports
9
RASH
17,151 reports
10
DIZZINESS
15,357 reports