PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Generic: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Amneal Pharmaceuticals LLCManufacturer
ORALRoute
PROMETHAZINE HYDROCHLORIDEActive Substance
2011-02-08Original Approval

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE is FDA application ANDA090575, sponsored by AMNEAL 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

Class II2014-05-08
PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd.,

Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet

Top Reported Reactions

1
DEPENDENCE
3,498 reports
2
OVERDOSE
754 reports
3
BACK PAIN
533 reports
4
NAUSEA
494 reports
5
PAIN
424 reports
6
VOMITING
351 reports
7
FATIGUE
348 reports
8
HEADACHE
329 reports
9
DIARRHOEA
297 reports
10
DEATH
291 reports