CLOMIPRAMINE HYDROCHLORIDE

Generic: CLOMIPRAMINE HYDROCHLORIDE

Ajanta Pharma USA Inc.Manufacturer

ORALRoute

CLOMIPRAMINE HYDROCHLORIDEActive Substance

2020-10-02Original Approval

CLOMIPRAMINE HYDROCHLORIDE is FDA application ANDA213897, 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 II2025-06-27

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation

Class III2022-08-23

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Phar

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

Class II2025-04-10

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation

Class II2025-10-22

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottle

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (

Class II2025-10-22

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottle

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (

Class II2025-10-22

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottle

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (

CLOMIPRAMINE HYDROCHLORIDE

Recalls

Top Reported Reactions