ALPRAZOLAM
Generic: ALPRAZOLAM
ANI PharmaceuticalsManufacturer
ORALRoute
ALPRAZOLAMActive Substance
1993-10-19Original Approval
ALPRAZOLAM is FDA application ANDA074174, sponsored by NOVITIUM PHARMA. 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 II2022-04-28
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 079Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II2013-10-09
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., ElizabetFailed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below speci
Class II2014-12-17
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLSubpotent Drug
Class II2014-07-25
Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Class II2014-02-10
Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora AvenueFailed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Al
Top Reported Reactions
1
DRUG ABUSE
8,821 reports
2
TOXICITY TO VARIOUS AGENTS
7,897 reports
3
COMPLETED SUICIDE
7,276 reports
4
DRUG INEFFECTIVE
7,093 reports
5
NAUSEA
5,792 reports
6
FATIGUE
5,511 reports
7
DEATH
5,108 reports
8
HEADACHE
4,587 reports
9
PAIN
4,490 reports
10
ANXIETY
4,342 reports