JAVYGTOR
Generic: SAPROPTERIN DIHYDROCHLORIDE
Dr. Reddys Laboratories IncManufacturer
ORALRoute
SAPROPTERIN DIHYDROCHLORIDEActive Substance
2021-06-15Original Approval
JAVYGTOR is FDA application ANDA207685, sponsored by DR REDDYS. 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 I2024-04-08
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, DistriSub-potent Drug; powder discoloration associated with decreased potency
Class III2024-11-22
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories IFailed Impurities/Degradation Specifications
Top Reported Reactions
1
OVERDOSE
147 reports
2
PRODUCT PRESCRIBING ERROR
143 reports
3
PRODUCT DOSE OMISSION ISSUE
95 reports
4
ILLNESS
48 reports
5
HEADACHE
44 reports
6
VOMITING
41 reports
7
EXPOSURE DURING PREGNANCY
40 reports
8
DIARRHOEA
37 reports
9
NAUSEA
34 reports
10
DRUG INEFFECTIVE
33 reports