AMLODIPINE AND OLMESARTAN MEDOXOMIL

Generic: AMLODIPINE AND OLMESARTAN MEDOXOMIL

Ascend LaboratoriesManufacturer
ORALRoute
AMLODIPINE BESYLATEActive Substance
2017-08-14Original Approval

AMLODIPINE AND OLMESARTAN MEDOXOMIL is FDA application ANDA209042, sponsored by ALKEM LABS 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 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
DRUG INEFFECTIVE
23 reports
2
HYPOTENSION
15 reports
3
DIARRHOEA
14 reports
4
ACUTE KIDNEY INJURY
13 reports
5
DIZZINESS
12 reports
6
HYPERTENSION
11 reports
7
INTENTIONAL OVERDOSE
11 reports
8
SPRUE-LIKE ENTEROPATHY
11 reports
9
TOXICITY TO VARIOUS AGENTS
10 reports
10
BLOOD PRESSURE INCREASED
9 reports