PITAVASTATIN CALCIUM
Generic: PITAVASTATIN CALCIUM
Zydus Lifesciences LimitedManufacturer
ORALRoute
PITAVASTATIN CALCIUMActive Substance
2023-02-22Original Approval
PITAVASTATIN CALCIUM is FDA application ANDA206047, sponsored by ZYDUS PHARMS. 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 III2025-06-26
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905Failed Impurity/Degradation Specifications
Class III2025-06-11
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Failed Impurities/Degradation Specifications.
Class III2026-02-03
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin ta
Class III2025-06-26
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906Failed Impurity/Degradation Specifications
Class III2025-06-11
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Failed Impurities/Degradation Specifications.
Top Reported Reactions
1
MYALGIA
445 reports
2
DIARRHOEA
350 reports
3
DIZZINESS
305 reports
4
DYSPNOEA
298 reports
5
NAUSEA
298 reports
6
HEADACHE
295 reports
7
DECREASED APPETITE
293 reports
8
FATIGUE
293 reports
9
MALAISE
285 reports
10
PRURITUS
285 reports