BISMUTH SUBCITRATE POTASSIUM
Generic: BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Par Health USAManufacturer
ORALRoute
BISMUTH SUBCITRATE POTASSIUMActive Substance
2023-03-06Original Approval
BISMUTH SUBCITRATE POTASSIUM is FDA application ANDA205770, sponsored by PH HEALTH. 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 I2020-03-23
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. EastFailed Dissolution Specifications: Out of specification result during long term testing in Tetracycl
Class I2020-03-23
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. EastFailed Dissolution Specifications: Out of specification result during long term testing in Tetracycl
Top Reported Reactions
1
OFF LABEL USE
223 reports
2
DRUG HYPERSENSITIVITY
152 reports
3
HYPERSENSITIVITY
125 reports
4
PNEUMONIA
105 reports
5
INTENTIONAL PRODUCT USE ISSUE
101 reports
6
PAIN IN EXTREMITY
95 reports
7
VOMITING
93 reports
8
ARTHRALGIA
91 reports
9
MOBILITY DECREASED
91 reports
10
NECK PAIN
90 reports