NYSTATIN AND TRIAMCINOLONE ACETONIDE
Generic: NYSTATIN AND TRIAMCINOLONE ACETONIDE
Alembic Pharmaceuticals Inc.Manufacturer
TOPICALRoute
NYSTATINActive Substance
2021-03-31Original Approval
NYSTATIN AND TRIAMCINOLONE ACETONIDE is FDA application ANDA214090, sponsored by ALEMBIC. 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 II2017-03-28
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributeFailed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class III2019-07-17
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin PharmacFailed Content Uniformity Specifications: Out-of-specification result observed in uniformity of cont
Top Reported Reactions
1
DRUG INEFFECTIVE
23 reports
2
PRODUCT USE IN UNAPPROVED INDICATION
11 reports
3
APPLICATION SITE PAIN
8 reports
4
PRURITUS
8 reports
5
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
6 reports
6
DIARRHOEA
5 reports
7
OFF LABEL USE
5 reports
8
PAIN
5 reports
9
RASH
5 reports
10
ACCIDENTAL EXPOSURE TO PRODUCT
4 reports