ALLOPURINOL
Generic: ALLOPURINOL
Mylan Pharmaceuticals Inc.Manufacturer
ORALRoute
ALLOPURINOLActive Substance
1986-10-24Original Approval
ALLOPURINOL is FDA application ANDA018659, sponsored by MYLAN. 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 II2023-01-12
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703,Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towa
Class III2015-07-20
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AFailed Tablet/Capsule Specifications; report of oversized and discolored tablets
Class II2024-06-07
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, ShrevPresence of foreign substance.
Class II2022-01-26
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC,CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi
Top Reported Reactions
1
DIARRHOEA
8,723 reports
2
FATIGUE
8,285 reports
3
DYSPNOEA
7,949 reports
4
NAUSEA
7,329 reports
5
DEATH
6,900 reports
6
ACUTE KIDNEY INJURY
6,761 reports
7
OFF LABEL USE
6,681 reports
8
PYREXIA
6,119 reports
9
PNEUMONIA
5,733 reports
10
ASTHENIA
5,653 reports