PREDNISOLONE ACETATE
Generic: PREDNISOLONE ACETATE
Lupin PharmaceuticalsManufacturer
OPHTHALMICRoute
PREDNISOLONE ACETATEActive Substance
2024-08-02Original Approval
PREDNISOLONE ACETATE is FDA application ANDA216935, sponsored by LUPIN. 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
TREATMENT FAILURE
1,250 reports
2
DRUG INEFFECTIVE
753 reports
3
OFF LABEL USE
480 reports
4
EYE PAIN
410 reports
5
FATIGUE
248 reports
6
EYE IRRITATION
235 reports
7
VISION BLURRED
225 reports
8
HEADACHE
223 reports
9
DIARRHOEA
212 reports
10
CONDITION AGGRAVATED
196 reports