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 II2019-05-06
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class III2014-10-10
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, C

Subpotent; 6 month stability time point

Class III2020-01-14
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to recons

Class II2019-05-06
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class III2014-09-11
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-45

Subpotent; 6 month stability time point

Class II2019-05-06
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India ND

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

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 on

Presence of Particulate Matter: Potential for black particulates in the drug product.

Class II2019-05-06
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Phar

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class II2026-01-15
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by:

Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister

Top Reported Reactions

1
OFF LABEL USE
22,059 reports
2
DRUG INEFFECTIVE
15,959 reports
3
FATIGUE
7,528 reports
4
PAIN
7,219 reports
5
HEADACHE
6,902 reports
6
NAUSEA
6,836 reports
7
PYREXIA
6,566 reports
8
PNEUMONIA
6,494 reports
9
ARTHRALGIA
6,088 reports
10
CONDITION AGGRAVATED
5,868 reports