QUETIAPINE FUMARATE

Generic: QUETIAPINE FUMARATE

Macleods Pharmaceuticals LimitedManufacturer
ORALRoute
QUETIAPINE FUMARATEActive Substance
2016-05-17Original Approval

QUETIAPINE FUMARATE is FDA application ANDA203359, sponsored by MACLEODS 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 III2020-02-27
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quet

Class III2020-02-27
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quet

Class III2020-02-27
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quet

Class II2018-11-14
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,

Presence of Foreign Substance; metal shard found in tablet

Class III2020-02-27
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin L

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quet

Top Reported Reactions

1
TOXICITY TO VARIOUS AGENTS
9,496 reports
2
DRUG INEFFECTIVE
8,685 reports
3
OFF LABEL USE
7,829 reports
4
DRUG INTERACTION
6,723 reports
5
COMPLETED SUICIDE
6,660 reports
6
FATIGUE
5,733 reports
7
NAUSEA
4,868 reports
8
CONDITION AGGRAVATED
4,851 reports
9
PAIN
4,753 reports
10
SOMNOLENCE
4,701 reports