METHYLPREDNISOLONE ACETATE
Generic: METHYLPREDNISOLONE ACETATE
Amneal Pharmaceuticals LLCManufacturer
INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUERoute
METHYLPREDNISOLONE ACETATEActive Substance
2023-11-03Original Approval
METHYLPREDNISOLONE ACETATE is FDA application ANDA216502, sponsored by AMNEAL. 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 II2024-02-20
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in Failed Dissolution Specifications
Class II2024-04-25
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx onPresence of Particulate Matter: Potential for black particulates in the drug product.
Top Reported Reactions
1
PAIN
1,016 reports
2
OFF LABEL USE
1,013 reports
3
RHEUMATOID ARTHRITIS
885 reports
4
DRUG INEFFECTIVE
818 reports
5
FATIGUE
760 reports
6
HEADACHE
752 reports
7
HEPATIC ENZYME INCREASED
588 reports
8
JOINT SWELLING
579 reports
9
DRUG HYPERSENSITIVITY
575 reports
10
RASH
565 reports