CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Generic: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sun Pharmaceutical IndustriesManufacturer
ORALRoute
CETIRIZINE HYDROCHLORIDEActive Substance
2012-09-28Original Approval

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE is FDA application ANDA090922, sponsored by SUN PHARM INDS LTD. 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 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 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 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

Class II2023-02-09
Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale

Failed Impurities/Degradation Specifications

Top Reported Reactions

1
DRUG INEFFECTIVE
28,191 reports
2
FATIGUE
23,863 reports
3
PAIN
19,712 reports
4
OFF LABEL USE
18,948 reports
5
HEADACHE
18,344 reports
6
NAUSEA
17,229 reports
7
DYSPNOEA
17,067 reports
8
RASH
14,723 reports
9
DIARRHOEA
14,472 reports
10
ARTHRALGIA
13,387 reports