PROPARACAINE HYDROCHLORIDE
Generic: PROPARACAINE HYDROCHLORIDE
Bausch & Lomb IncorporatedManufacturer
OPHTHALMICRoute
PROPARACAINE HYDROCHLORIDEActive Substance
1995-09-29Original Approval
PROPARACAINE HYDROCHLORIDE is FDA application ANDA040074, sponsored by BAUSCH AND LOMB INC. 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 II2019-07-02
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx onlyLack of Assurance of Sterility
Class II2024-09-11
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208Temperature abuse: Products exposed to improper temperature above drug label specifications.
Top Reported Reactions
1
OFF LABEL USE
52 reports
2
VOMITING
18 reports
3
ABDOMINAL DISTENSION
17 reports
4
APNOEA
16 reports
5
FEEDING INTOLERANCE
16 reports
6
GASTRIC RESIDUAL INCREASED
16 reports
7
EYE PAIN
14 reports
8
PRODUCT USE IN UNAPPROVED INDICATION
11 reports
9
TRANSMISSION OF AN INFECTIOUS AGENT VIA PRODUCT
11 reports
10
VISION BLURRED
11 reports