The Recall Desk
ModerateFDA (Drugs)·D-0110-2021·Announced 2020-12-02

Teligent Recalls Subpotent Triamcinolone Acetonide Lotion

Teligent Pharma is recalling one lot of Triamcinolone Acetonide Lotion because it does not meet assay results.

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: 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
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.