AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL

Generic: AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL

Ajanta Pharma USA Inc.Manufacturer
ORALRoute
AMLODIPINE BESYLATEActive Substance
2016-10-28Original Approval

AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL is FDA application ANDA207216, sponsored by AJANTA PHARMA LTD. 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 II2020-01-24
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4

cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source

Class III2021-04-29
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013.

Presence of Foreign Tablet/Capsule

Class III2018-11-30
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA,

Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from

Class II2025-07-21
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories

Failed Dissolution Specifications: low dissolution results

Class II2022-02-15
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma

cGMP deviations

Class II2026-05-05
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Class II2026-07-08
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laborat

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Class II2021-03-15
Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods P

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DIARRHOEA
940 reports
2
WEIGHT DECREASED
930 reports
3
DRUG INEFFECTIVE
633 reports
4
NAUSEA
605 reports
5
FATIGUE
572 reports
6
DIZZINESS
535 reports
7
DYSPNOEA
512 reports
8
HYPOTENSION
497 reports
9
VOMITING
445 reports
10
BLOOD PRESSURE INCREASED
422 reports