The Recall Desk
ModerateFDA (Drugs)·D-0677-2022·Announced 2022-03-30

Desoximetasone Ointment USP 0.05% Recall Due to cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Desoximetasone Ointment USP 0.05% (54,897 tubes) distributed nationwide because the manufacturer is discontinuing its stability study program, a violation of current good manufacturing practices.

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 states only a regulatory violation (discontinuation of stability studies) with no reported illnesses, injuries, or deaths. Per the rubric, Class II recalls without hospitalization reports or injury reports are typically scored 2 (Moderate).

Plain-English summary

Teligent Pharma, Inc. is recalling Desoximetasone Ointment USP 0.05% in 100-gram and 60-gram tubes (NDC 52565-045-99 and NDC 52565-045-60, respectively) distributed nationwide in the USA and Puerto Rico. The recall affects all products within expiry. The affected batches are: 100-gram tubes (Batch 15196, Exp. 2/28/2022; Batch 16605, Exp. 3/31/2023) and 60-gram tubes (Batch 15190, Exp. 2/28/2022; Batch 16660, Exp. 4/30/2023; Batch 17037, Exp. 6/30/2023; Batch 17163, Exp. 8/31/2023). A total of 54,897 tubes are affected.

The recall is due to current good manufacturing practice (cGMP) deviations. Specifically, Teligent Pharma is discontinuing its stability study program, which is required to ensure drug quality and safety throughout the product's shelf life. This is a Class II recall by FDA classification.

Patients should not stop using this medication without consulting their healthcare provider. Consumers who have this product should contact their pharmacy or healthcare provider for instructions on obtaining a replacement or alternative treatment. Healthcare providers and patients may report adverse events related to this recall to the FDA MedWatch program.

The recalled product

Product
Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
  • cgmp-deviation
  • stability-study-discontinuation

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 (11)

  • Batch: a) 15196
  • Exp. 2/28/2022
  • 16605
  • Exp. 3/31/2023
  • b)15190
  • 16660
  • Exp. 4/30/2023
  • 17037
  • Exp. 6/30/2023
  • 17163
  • Exp. 8/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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