ROSUVASTATIN
Generic: ROSUVASTATIN
Accord Healthcare Inc.Manufacturer
ORALRoute
ROSUVASTATIN CALCIUMActive Substance
2016-10-31Original Approval
ROSUVASTATIN is FDA application ANDA206434, sponsored by ACCORD HLTHCARE. 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 II2023-02-07
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,0CGMP Deviations: recalling drug products following an FDA inspection.
Class II2025-03-13
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyCGMP Deviations
Class II2023-02-07
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-cCGMP Deviations: recalling drug products following an FDA inspection.
Class II2025-12-31
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, Out of specification for dissolution.
Class II2023-02-07
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) CGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-02-07
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1CGMP Deviations: recalling drug products following an FDA inspection.
Top Reported Reactions
1
FATIGUE
8,481 reports
2
DYSPNOEA
7,316 reports
3
DRUG INEFFECTIVE
6,757 reports
4
NAUSEA
6,654 reports
5
OFF LABEL USE
6,605 reports
6
DIARRHOEA
6,323 reports
7
PAIN
6,109 reports
8
HEADACHE
5,561 reports
9
ARTHRALGIA
5,085 reports
10
COUGH
4,820 reports