Triamcinolone Acetonide Cream Recalled for Manufacturing Defects
Padagis US LLC is recalling 57,816 tubes of Triamcinolone Acetonide Cream 0.1% nationwide due to manufacturing process deviations. Consumers reported gritty texture and reduced effectiveness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with CGMP deviations affecting product quality and effectiveness, but no reported illnesses, injuries, or adverse health events. The product complaints involve manufacturing defects and therapeutic failure, not direct safety hazards causing harm.
Plain-English summary
Padagis US LLC is recalling Triamcinolone Acetonide Cream USP, 0.1%, 80 gram tubes nationwide. The affected product is Lot 2CT0486 with an expiration date of 02/29/2024. NDC 45802-064-36.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Consumer complaints reported the product to have a gritty texture and lack of effectiveness.
The product was distributed nationwide in the United States. Patients should consult their healthcare provider about alternative treatment options and may return the medication to their pharmacy for proper disposal.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
- Brand
- TRIAMCINOLONE ACETONIDE
- Manufacturer
- Padagis US LLC
- Category
- Drug — Topical Corticosteroid
- Hazard
- manufacturing-defect
- gritty-texture
- lack-of-effectiveness
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 2CT0486
- Exp 02/29/2024
Distribution
Distributed nationwide across the United States.
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