DESIPRAMINE HYDROCHLORIDE

Generic: DESIPRAMINE HYDROCHLORIDE

Actavis PharmaManufacturer
ORALRoute
DESIPRAMINE HYDROCHLORIDEActive Substance
1987-10-05Original Approval

DESIPRAMINE HYDROCHLORIDE is FDA application ANDA071766, sponsored by ACTAVIS TOTOWA. 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 II2025-10-06
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Privat

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake le

Class II2025-10-06
Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Privat

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake le

Class II2025-10-06
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Priv

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake le

Class II2025-10-06
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Privat

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake le

Class II2025-10-06
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Priva

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake le

Class II2025-10-06
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Privat

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake le

Top Reported Reactions

1
DRUG INEFFECTIVE
17 reports
2
TOXICITY TO VARIOUS AGENTS
15 reports
3
FATIGUE
14 reports
4
HEADACHE
12 reports
5
DYSPNOEA
11 reports
6
NAUSEA
11 reports
7
DRUG HYPERSENSITIVITY
10 reports
8
PRODUCT DOSE OMISSION ISSUE
10 reports
9
COMPLETED SUICIDE
9 reports
10
CONFUSIONAL STATE
9 reports