DILTIAZEM HYDROCHLORIDE
Generic: DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE is FDA application ANDA217377, sponsored by TWI PHARMS. 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
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim li
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed
CGMP Deviations
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim li
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim li
Failed Dissolution Specifications