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 III2019-07-29
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufac

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B i

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 II2023-02-07
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000

CGMP Deviations: recalling drug products following an FDA inspection.

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 II2023-02-07
Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-c

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-co

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-c

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,00

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
FATIGUE
11,392 reports
2
NAUSEA
10,574 reports
3
DYSPNOEA
10,347 reports
4
DIARRHOEA
10,169 reports
5
DRUG INEFFECTIVE
9,286 reports
6
DIZZINESS
9,126 reports
7
FALL
7,689 reports
8
HEADACHE
7,396 reports
9
PAIN
7,195 reports
10
ASTHENIA
7,175 reports