DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Generic: DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Bionpharma Inc.Manufacturer
ORALRoute
DOXYLAMINE SUCCINATEActive Substance
2023-08-04Original Approval
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is FDA application ANDA217000, sponsored by BIONPHARMA. 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 II2022-01-18
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, ManufaFailed Dissolution Specification: Dissolution results are below specification limits for the active
Class III2026-08-07
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, DPresence of Foreign Tablets/Capsules
Top Reported Reactions
1
MATERNAL EXPOSURE DURING PREGNANCY
11 reports
2
OFF LABEL USE
11 reports
3
EXPOSURE DURING PREGNANCY
10 reports
4
SEROTONIN SYNDROME
10 reports
5
ABORTION SPONTANEOUS
8 reports
6
DRUG INEFFECTIVE
8 reports
7
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
8 reports
8
AKATHISIA
5 reports
9
OCULOGYRIC CRISIS
5 reports
10
ANAPHYLACTIC REACTION
4 reports