TEMOZOLOMIDE

Generic: TEMOZOLOMIDE

Accord Healthcare Inc.Manufacturer
ORALRoute
TEMOZOLOMIDEActive Substance
2017-02-27Original Approval

TEMOZOLOMIDE is FDA application ANDA201528, sponsored by ACCORD HLTHCARE. 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 II2026-03-03
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceutic

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-mon

Class II2019-07-16
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14),

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with bet

Class II2019-07-16
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14),

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with bet

Class II2019-07-16
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), R

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with bet

Class II2019-07-16
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with bet

Class II2019-07-16
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14),

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with bet

Class II2019-07-16
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with bet

Top Reported Reactions

1
DISEASE PROGRESSION
1,641 reports
2
DEATH
1,369 reports
3
THROMBOCYTOPENIA
1,336 reports
4
OFF LABEL USE
1,279 reports
5
DRUG INEFFECTIVE
1,071 reports
6
NAUSEA
973 reports
7
NEUTROPENIA
892 reports
8
MALIGNANT NEOPLASM PROGRESSION
757 reports
9
FEBRILE NEUTROPENIA
753 reports
10
VOMITING
739 reports