PREDNISOLONE ACETATE
Generic: PREDNISOLONE ACETATE
Sandoz IncManufacturer
OPHTHALMICRoute
PREDNISOLONE ACETATEActive Substance
1973-07-10Original Approval
PREDNISOLONE ACETATE is FDA application NDA017469, sponsored by SANDOZ. 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 II2026-06-04
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-3Presence of Foreign Substance
Class II2022-04-13
Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05cGMP deviations: Temperature abuse
Top Reported Reactions
1
OFF LABEL USE
16,124 reports
2
DRUG INEFFECTIVE
13,641 reports
3
PYREXIA
8,768 reports
4
DYSPNOEA
7,327 reports
5
PNEUMONIA
7,241 reports
6
DIARRHOEA
7,013 reports
7
CONDITION AGGRAVATED
6,282 reports
8
NAUSEA
5,782 reports
9
FATIGUE
5,475 reports
10
VOMITING
5,384 reports