DAPTOMYCIN
Generic: DAPTOMYCIN
Dr.Reddy's Laboratories Inc.Manufacturer
INTRAVENOUSRoute
DAPTOMYCINActive Substance
2019-05-01Original Approval
DAPTOMYCIN is FDA application ANDA208375, sponsored by DR REDDYS. 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 I2020-07-07
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, RPresence of Particulate Matter
Class II2023-02-07
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, PhaCGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-02-07
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b)CGMP Deviations: recalling drug products following an FDA inspection.
Top Reported Reactions
1
DRUG INEFFECTIVE
753 reports
2
OFF LABEL USE
694 reports
3
ACUTE KIDNEY INJURY
599 reports
4
PYREXIA
477 reports
5
EOSINOPHILIC PNEUMONIA
463 reports
6
RHABDOMYOLYSIS
370 reports
7
EOSINOPHILIA
364 reports
8
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
334 reports
9
BLOOD CREATINE PHOSPHOKINASE INCREASED
331 reports
10
PRODUCT USE IN UNAPPROVED INDICATION
301 reports