LOVASTATIN
Generic: LOVASTATIN
Teva Pharmaceuticals USAManufacturer
ORALRoute
LOVASTATINActive Substance
2001-12-17Original Approval
LOVASTATIN is FDA application ANDA075551, sponsored by TEVA. 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 III2019-02-13
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, RxCGMP Deviations: Finished product made with lovastatin drug substance that was out of specification
Class III2019-02-19
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-3CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification
Top Reported Reactions
1
DRUG INEFFECTIVE
1,683 reports
2
FATIGUE
1,537 reports
3
NAUSEA
1,402 reports
4
DIARRHOEA
1,275 reports
5
DYSPNOEA
1,227 reports
6
DIZZINESS
1,161 reports
7
PAIN
1,070 reports
8
HEADACHE
1,015 reports
9
ASTHENIA
985 reports
10
FALL
909 reports