Drugplain

TRIAMCINOLONE ACETONIDE 1 mg/g

TRIAMCINOLONE ACETONIDE · PASTE · QUAGEN PHARMACEUTICALS LLC

10 Recalls on RecordCurrently in Shortage
Plain English

TRIAMCINOLONE ACETONIDE is a paste containing triamcinolone acetonide at 1 mg/g, taken dental. Manufactured by QUAGEN PHARMACEUTICALS LLC.

Key Facts

Brand Name
TRIAMCINOLONE ACETONIDE
Generic Name
TRIAMCINOLONE ACETONIDE
NDC Code (Product)
70752-140
Manufacturer
QUAGEN PHARMACEUTICALS LLC
Strength
1 mg/g
Dosage Form
PASTE
Route
DENTAL
Marketing Status
Application #
ANDA214582
Drug Class
Corticosteroid [EPC]
Marketing Start
01/15/2023

Recall History

10 Recalls on Record
Class III10/11/2024

Padagis US LLC

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II09/21/2018

Dr. Reddy's Laboratories, Inc.

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.

TerminatedVoluntary: Firm initiated
Class II05/21/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated
Class III11/03/2020

Teligent Pharma, Inc.

Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II04/17/2013

Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

TerminatedVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II07/19/2021

Teligent Pharma, Inc.

Correct Labeled Product Mispack

TerminatedVoluntary: Firm initiated
Class II07/26/2013

Beacon Hill Medical Pharmacy, P.C.

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,546 reports
off label use2,621 reports
pruritus2,265 reports
rash2,238 reports
pain1,937 reports
fatigue1,850 reports
nausea1,766 reports
product use in unapproved indication1,582 reports
vomiting1,546 reports
condition aggravated1,533 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS & USAGE Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Dosage & Administration

DOSAGE & ADMINISTRATION Apply a thin film of Triamcinolone Acetonide Ointment 0.025% to the affected area two to four times daily. Apply a thin film of the 0.1% or the 0.5% Triamcinolone Acetonide Ointment, as appropriate, to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply Triamcinolone Acetonide Ointment under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of

Contraindications

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Adverse Reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Frequently Asked Questions

What is TRIAMCINOLONE ACETONIDE used for?

TRIAMCINOLONE ACETONIDE contains TRIAMCINOLONE ACETONIDE. It is a paste taken dental. Consult your doctor for specific uses.

Is TRIAMCINOLONE ACETONIDE a controlled substance?

TRIAMCINOLONE ACETONIDE is not classified as a controlled substance by the DEA.

What is the generic name for TRIAMCINOLONE ACETONIDE?

The generic name for TRIAMCINOLONE ACETONIDE is TRIAMCINOLONE ACETONIDE. There are 11 other brand versions of TRIAMCINOLONE ACETONIDE.

What is the NDC code for TRIAMCINOLONE ACETONIDE 1 mg/g?

The NDC (National Drug Code) for TRIAMCINOLONE ACETONIDE 1 mg/g is 70752-140, listed by QUAGEN PHARMACEUTICALS LLC.