FENOFIBRATE

Generic: FENOFIBRATE

Sun Pharmaceutical IndustriesManufacturer

ORALRoute

FENOFIBRATEActive Substance

2014-10-31Original Approval

FENOFIBRATE is FDA application ANDA201748, sponsored by SUN PHARM INDS LTD. 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 II2025-03-13

Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur

CGMP Deviations

Class II2021-03-15

FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class II2026-05-28

Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Aja

CGMP Deviations

Class III2018-09-12

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, N

Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingle

Top Reported Reactions

1

FATIGUE

2,153 reports

2

DIARRHOEA

2,087 reports

3

NAUSEA

2,025 reports

4

DRUG INEFFECTIVE

1,772 reports

5

HEADACHE

1,557 reports

6

DYSPNOEA

1,512 reports

7

OFF LABEL USE

1,379 reports

8

DIZZINESS

1,371 reports

9

PAIN

1,362 reports

10

FALL

1,356 reports