HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Generic: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Genus Lifesciences Inc.Manufacturer
ORALRoute
HYDROCODONE BITARTRATEActive Substance
1943-03-23Original Approval
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE is FDA application NDA005213, sponsored by GENUS. 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 III2018-03-05
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: NovFailed Impurities/Degradation Specifications
Class III2021-04-27
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-TFailed Impurities/Degradation Specifications
Class II2019-11-01
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. bPresence of Foreign Substance: Black particles were found in the lots during retain sample inspectio
Top Reported Reactions
1
ABDOMINAL PAIN UPPER
3 reports
2
CONSTIPATION
3 reports
3
DECREASED APPETITE
3 reports
4
DIZZINESS
3 reports
5
HYPERSENSITIVITY
3 reports
6
INJECTION SITE RASH
3 reports
7
NAUSEA
3 reports
8
ADVERSE DRUG REACTION
2 reports
9
CHRONIC KIDNEY DISEASE
2 reports
10
DIARRHOEA
2 reports