Desoximetasone Ointment USP 0.05% Recalled Due to cGMP Deviations
Teligent Pharma is recalling Desoximetasone Ointment USP 0.05% nationwide due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, affecting all products within expiry.
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. The source text states no illnesses or injuries have been reported, and the hazard is regulatory/procedural (discontinuation of stability studies) rather than an acute safety threat. The recall is precautionary in nature.
Plain-English summary
Teligent Pharma, Inc. is recalling Desoximetasone Ointment USP, 0.05%, in 100-gram tubes manufactured for SOLA Pharmaceuticals. The recall includes all products within expiration dates from batches 15996 and 15997 (expiration 9/30/2022). The recall covers approximately 6,850 tubes distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to current good manufacturing practice (cGMP) deviations. Specifically, the firm is discontinuing its stability study program, which is required to ensure product safety and efficacy throughout the stated shelf life.
Consumers and healthcare providers in possession of affected batches should stop using the product and consult their healthcare provider about alternative treatment options. Patients should not discontinue use without medical guidance.
The recalled product
- Product
- Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- cgmp-deviation
- discontinued-stability-study
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 (3)
- Batch: 15996
- 15997
- Exp. 9/30/2022
Distribution
Distributed nationwide across the United States.
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