PHENYLEPHRINE HYDROCHLORIDE

Generic: PHENYLEPHRINE HYDROCHLORIDE

Provepharm Inc.Manufacturer
INTRAVENOUSRoute
PHENYLEPHRINE HYDROCHLORIDEActive Substance
2020-07-17Original Approval

PHENYLEPHRINE HYDROCHLORIDE is FDA application ANDA211081, sponsored by MILLA PHARMS. 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 II2021-03-11
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per ca

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result

Top Reported Reactions

1
OFF LABEL USE
1,321 reports
2
PEMPHIGUS
1,039 reports
3
JOINT SWELLING
1,001 reports
4
PAIN
969 reports
5
RHEUMATOID ARTHRITIS
958 reports
6
INFUSION RELATED REACTION
950 reports
7
DRUG INEFFECTIVE
948 reports
8
SYSTEMIC LUPUS ERYTHEMATOSUS
948 reports
9
PERICARDITIS
944 reports
10
MATERNAL EXPOSURE DURING PREGNANCY
940 reports