TRIAMCINOLONE ACETONIDE

Generic: TRIAMCINOLONE ACETONIDE

Hikma Pharmaceuticals USA Inc.Manufacturer
INTRA-ARTICULAR, INTRAMUSCULARRoute
TRIAMCINOLONE ACETONIDEActive Substance
2024-12-09Original Approval

TRIAMCINOLONE ACETONIDE is FDA application ANDA215254, sponsored by HIKMA. 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 II2021-03-15
Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class II2022-04-13
Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15

cGMP deviations: Temperature abuse

Class II2017-03-28
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distribute

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

Class II2022-08-17
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Pe

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effec

Class II2023-09-28
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For I

Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. Th

Class II2022-09-12
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534,

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effec

Class III2014-01-29
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Phar

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rathe

Class III2019-07-17
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmac

Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of cont

Top Reported Reactions

1
DRUG INEFFECTIVE
3,716 reports
2
OFF LABEL USE
2,755 reports
3
PRURITUS
2,522 reports
4
RASH
2,420 reports
5
PAIN
2,041 reports
6
FATIGUE
1,943 reports
7
NAUSEA
1,854 reports
8
PRODUCT USE IN UNAPPROVED INDICATION
1,673 reports
9
VOMITING
1,628 reports
10
DIARRHOEA
1,608 reports