ORPHENADRINE CITRATE

Generic: ORPHENADRINE CITRATE

Actavis PharmaManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
ORPHENADRINE CITRATEActive Substance
1982-03-15Original Approval

ORPHENADRINE CITRATE is FDA application ANDA084779, sponsored by WATSON LABS. 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 II2022-03-21
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,

CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

Class III2014-07-11
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (ND

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability t

Top Reported Reactions

1
PAIN
65 reports
2
NAUSEA
52 reports
3
FATIGUE
48 reports
4
ANXIETY
46 reports
5
DRUG INEFFECTIVE
45 reports
6
ARTHRALGIA
41 reports
7
HEADACHE
41 reports
8
DIZZINESS
37 reports
9
DIARRHOEA
36 reports
10
DYSPNOEA
31 reports