The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0676-2022·Announced 2022-03-30

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.

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. 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
Affected units
6,850

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

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