Fluocinonide Topical Solution Recalled Due to Manufacturing Deviations
Teligent Pharma recalled Fluocinonide Topical Solution USP 0.05% nationwide because the manufacturer is discontinuing stability testing. Without ongoing verification, the company cannot ensure product safety.
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The recall is precautionary, initiated due to manufacturing compliance deviations and discontinuation of stability testing rather than reported product harm.
Plain-English summary
Teligent Pharma, Inc. is recalling Fluocinonide Topical Solution USP, 0.05%, a prescription topical corticosteroid. The recall includes approximately 7,169 bottles in two package sizes: 20 mL bottles (NDC 52565-025-20) and 60 mL bottles (NDC 52565-025-59). The affected batch is 17138, with an expiration date of February 28, 2023.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations. The manufacturer is discontinuing its stability study program, which is required to verify that medications maintain their quality and safety throughout their shelf life.
The recalled product was distributed nationwide in the United States and Puerto Rico.
Consumers or healthcare providers who have this medication should stop using it and consult a healthcare professional about appropriate alternatives. The product should be returned to the pharmacy or disposed of according to local guidelines.
The recalled product
- Product
- Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- manufacturing-deviation
- stability-testing-discontinued
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)
- Batch: 17138
- Exp. 2/28/2023
Distribution
Distributed nationwide across the United States.
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