MIRTAZAPINE

Generic: MIRTAZAPINE

Aurolife Pharma LLCManufacturer
ORALRoute
MIRTAZAPINEActive Substance
2004-10-22Original Approval

MIRTAZAPINE is FDA application ANDA076921, sponsored by AUROBINDO. 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 II2017-01-19
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc.,

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

Class I2019-11-20
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 0881

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottl

Class I2019-11-20
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 088

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottl

Class II2020-03-18
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, N

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class II2017-01-27
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morganto

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

Top Reported Reactions

1
FATIGUE
3,907 reports
2
NAUSEA
3,882 reports
3
DRUG INEFFECTIVE
3,745 reports
4
TOXICITY TO VARIOUS AGENTS
3,656 reports
5
FALL
3,385 reports
6
OFF LABEL USE
3,361 reports
7
DIARRHOEA
3,334 reports
8
DRUG INTERACTION
2,998 reports
9
DIZZINESS
2,910 reports
10
DEATH
2,831 reports