LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Generic: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Camber Consumer Care IncManufacturer
ORALRoute
LOPERAMIDE HYDROCHLORIDEActive Substance
2021-06-17Original Approval

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE is FDA application ANDA211438, sponsored by HETERO LABS LTD V. 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 III2018-12-26
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indi

Class II2022-04-13
Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01

cGMP deviations: Temperature abuse

Top Reported Reactions

1
DIARRHOEA
1,684 reports
2
DRUG INEFFECTIVE
1,353 reports
3
OFF LABEL USE
1,009 reports
4
NAUSEA
944 reports
5
INTENTIONAL PRODUCT USE ISSUE
872 reports
6
FATIGUE
792 reports
7
CONSTIPATION
597 reports
8
PYREXIA
585 reports
9
VOMITING
562 reports
10
WEIGHT DECREASED
480 reports