TELMISARTAN AND HYDROCHLOROTHIAZIDE

Generic: TELMISARTAN AND HYDROCHLOROTHIAZIDE

Solco Healthcare LLCManufacturer

ORALRoute

TELMISARTANActive Substance

2017-11-06Original Approval

TELMISARTAN AND HYDROCHLOROTHIAZIDE is FDA application ANDA209028, sponsored by PRINSTON INC. 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 III2019-04-01

Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,

Failed Impurities/Degradation Specifications; 18 month long term stability study.

Class I2021-03-17

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation

Labeling: Label-mixup

Class II2022-06-29

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuti

Defective Container: Recall of these batches has been initiated due to complaints of difficult to o

Class II2022-06-29

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceu

Defective Container: Recall of these batches has been initiated due to complaints of difficult to o

Top Reported Reactions

1

FATIGUE

1,474 reports

2

NAUSEA

1,383 reports

3

DRUG INEFFECTIVE

1,261 reports

4

DIARRHOEA

1,237 reports

5

HEADACHE

1,224 reports

6

DYSPNOEA

1,174 reports

7

OFF LABEL USE

1,165 reports

8

FALL

1,130 reports

9

ARTHRALGIA

1,050 reports

10

ASTHENIA

1,011 reports