EZETIMIBE AND SIMVASTATIN

Generic: EZETIMIBE AND SIMVASTATIN

Aurobindo Pharma LimitedManufacturer
ORALRoute
EZETIMIBEActive Substance
2020-12-17Original Approval

EZETIMIBE AND SIMVASTATIN is FDA application ANDA200082, sponsored by AUROBINDO PHARMA USA. 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 II2021-03-15
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class II2021-10-14
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Labor

Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using

Class II2021-10-05
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-9

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conduct

Class II2021-10-05
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-9

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conduct

Class II2021-10-05
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-9

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conduct

Class II2021-10-05
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's La

Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using

Class II2021-10-14
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA

Failed Excipient Specification; product manufactured using an excipient found to be OOS for conducti

Class II2021-10-05
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conduct

Class III2025-05-19
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test

Top Reported Reactions

1
FATIGUE
2,795 reports
2
MYALGIA
2,625 reports
3
NAUSEA
2,319 reports
4
DIARRHOEA
2,201 reports
5
DYSPNOEA
2,024 reports
6
DIZZINESS
1,955 reports
7
HEADACHE
1,902 reports
8
DRUG INEFFECTIVE
1,861 reports
9
ARTHRALGIA
1,671 reports
10
ASTHENIA
1,618 reports