BUSPIRONE HYDROCHLORIDE

Generic: BUSPIRONE HYDROCHLORIDE

Strides Pharma Inc.Manufacturer
ORALRoute
BUSPIRONE HYDROCHLORIDEActive Substance
2014-08-25Original Approval

BUSPIRONE HYDROCHLORIDE is FDA application ANDA202330, sponsored by STRIDES 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 II2023-02-07
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,

CGMP Deviations: recalling drug products following an FDA inspection.

Class III2023-10-27
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 061

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within

Class II2023-02-07
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b)

CGMP Deviations: recalling drug products following an FDA inspection.

Class III2023-10-27
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card

Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within

Class II2023-03-16
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indian

CGMP Deviations

Class II2023-02-07
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2021-05-05
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Bir

Presence of Foreign Tablets/Capsules

Class II2023-02-07
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham

CGMP Deviations: recalling drug products following an FDA inspection.

Class III2026-04-13
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, A

Subpotent drug

Class II2023-02-07
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham,

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
DRUG INEFFECTIVE
197 reports
2
NAUSEA
160 reports
3
FATIGUE
158 reports
4
ANXIETY
152 reports
5
OFF LABEL USE
142 reports
6
HEADACHE
138 reports
7
DIZZINESS
119 reports
8
TREMOR
97 reports
9
SUICIDAL IDEATION
92 reports
10
DEPRESSION
89 reports