OXYBUTYNIN CHLORIDE
Generic: OXYBUTYNIN CHLORIDE
TruPharma LLCManufacturer
ORALRoute
OXYBUTYNIN CHLORIDEActive Substance
2018-09-06Original Approval
OXYBUTYNIN CHLORIDE is FDA application ANDA210125, sponsored by TP ANDA HOLDINGS. 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 II2018-12-11
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702Labeling: Wrong bar code
Class III2019-03-01
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-Failed Dissolution Specifications
Class III2019-02-21
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, PhiFailed Dissolution Specifications
Top Reported Reactions
1
FATIGUE
729 reports
2
DRUG INEFFECTIVE
695 reports
3
NAUSEA
602 reports
4
FALL
579 reports
5
HEADACHE
557 reports
6
DIARRHOEA
507 reports
7
PAIN
481 reports
8
URINARY TRACT INFECTION
446 reports
9
DIZZINESS
434 reports
10
CONSTIPATION
402 reports