Teligent Recalls Subpotent Triamcinolone Acetonide Lotion
Teligent Pharma is recalling one lot of Triamcinolone Acetonide Lotion because it does not meet assay results.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, fitting the criteria for a moderate severity score due to the subpotent nature of the drug without reported injuries.
Plain-English summary
Teligent Pharma, Inc. is recalling one lot of Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL bottles. The product is identified by Lot # 14481 and has an expiration date of 10/31/2021.
The recall was initiated because the product does not meet assay results, meaning it is subpotent. A total of 4,008 units were distributed nationwide in the USA.
Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or further instructions.
The recalled product
- Product
- Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 4,008
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 (1)
- Lot #: 14481 Exp 10/31/2021
Distribution
Distributed nationwide across the United States.
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