HYDROXYZINE PAMOATE
Generic: HYDROXYZINE PAMOATE
Sandoz IncManufacturer
ORALRoute
HYDROXYZINE PAMOATEActive Substance
1981-12-14Original Approval
HYDROXYZINE PAMOATE is FDA application ANDA086183, sponsored by SANDOZ. 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 II2014-01-24
Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, SellCGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved mat
Class II2022-04-13
HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01cGMP deviations: Temperature abuse
Class II2014-01-24
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, SellCGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved mate
Top Reported Reactions
1
COMPLETED SUICIDE
307 reports
2
DRUG INEFFECTIVE
284 reports
3
NAUSEA
225 reports
4
FATIGUE
214 reports
5
DRUG HYPERSENSITIVITY
200 reports
6
PAIN
189 reports
7
HEADACHE
168 reports
8
ANXIETY
166 reports
9
PRURITUS
162 reports
10
OFF LABEL USE
153 reports