CLONIDINE TRANSDERMAL SYSTEM

Generic: CLONIDINE

Actavis PharmaManufacturer
TRANSDERMALRoute
CLONIDINEActive Substance
2014-05-06Original Approval

CLONIDINE TRANSDERMAL SYSTEM is FDA application ANDA090873, sponsored by ACTAVIS LABS UT 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 III2014-07-17
Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL c

Class II2026-03-19
Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufact

CGMP Deviations: use of an unapproved raw material

Class II2022-06-09
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufac

Defective Delivery System: Out of specification for release liner removal force results at the 3-mo

Class III2020-05-26
Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Piler

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level

Class III2020-01-29
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilern

Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure du

Class II2026-03-19
Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufact

CGMP Deviations: use of an unapproved raw material

Class II2026-03-19
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufact

CGMP Deviations: use of an unapproved raw material

Class III2021-10-28
Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT I

Failed Impurities/Degradation Specifications

Class III2019-03-29
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut

Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as

Class III2022-09-19
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pile

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg

Top Reported Reactions

1
DRUG INEFFECTIVE
4,340 reports
2
PAIN
3,487 reports
3
FATIGUE
3,481 reports
4
NAUSEA
3,439 reports
5
OFF LABEL USE
3,402 reports
6
HEADACHE
3,373 reports
7
HYPERTENSION
3,179 reports
8
DYSPNOEA
2,710 reports
9
DIARRHOEA
2,646 reports
10
VOMITING
2,444 reports