Triamcinolone Acetonide Cream Recalled Due to Manufacturing Quality Defects
Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The defect is a manufacturing quality control issue affecting product texture and effectiveness rather than inherent safety. Per the rubric, no harm has been reported and the hazard is quality-based rather than safety-based, warranting Score 2 (Moderate).
Plain-English summary
Direct Rx is recalling Triamcinolone Acetonide cream, 0.1%, in 80-gram tubes distributed to physicians and medical facilities in Georgia and Idaho. The affected lot number is 12JY2216, with an expiration date of February 29, 2024, and approximately 20 tubes are involved.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Product complaints reported that the cream has a gritty texture and lacks effectiveness, indicating manufacturing quality control failures.
The recalled product
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: 12JY2216
- Exp. 2/29/24
Distribution
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