RIZATRIPTAN BENZOATE

Generic: RIZATRIPTAN BENZOATE

Glenmark Pharmaceuticals Inc.Manufacturer
ORALRoute
RIZATRIPTAN BENZOATEActive Substance
2013-07-01Original Approval

RIZATRIPTAN BENZOATE is FDA application ANDA201914, sponsored by GLENMARK PHARMS 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 III2021-10-18
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled

Class II2024-05-13
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark P

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable

Class II2025-07-09
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acc

Class II2024-05-10
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., US

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable

Class II2024-05-13
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Ph

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable

Class III2021-10-18
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled

Class II2024-05-10
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc.,

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable

Class II2025-07-09
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd.,

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acc

Top Reported Reactions

1
DRUG INEFFECTIVE
388 reports
2
HEADACHE
244 reports
3
NAUSEA
224 reports
4
OFF LABEL USE
221 reports
5
MIGRAINE
201 reports
6
PRODUCT USE IN UNAPPROVED INDICATION
168 reports
7
DRUG INTOLERANCE
163 reports
8
HYPERSENSITIVITY
157 reports
9
FATIGUE
136 reports
10
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
122 reports