The Recall Desk
ModerateFDA (Drugs)·D-0678-2022·Announced 2022-03-30

Desoximetasone Ointment USP Recalled by Teligent Pharma

Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.

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 involving a cGMP deviation (discontinuation of stability studies). The source text does not report any illnesses, injuries, or hospitalization. The hazard is regulatory/manufacturing compliance–related rather than an identified product safety threat, which places this in the Moderate category.

Plain-English summary

Teligent Pharma, Inc. is recalling Desoximetasone Ointment USP, 0.25%, in three package sizes: 100 gram tubes (NDC 52565-030-99), 60 gram tubes (NDC 52565-030-60), and 15 gram tubes (NDC 52565-030-15). A total of 13,989 tubes are affected.

The recall was initiated because the manufacturer is discontinuing its stability study program, which constitutes a deviation from current Good Manufacturing Practice (cGMP) regulations. All products within expiry dates are included in this recall.

The recalled product has been distributed nationwide in the USA and Puerto Rico. Affected batch numbers and expiration dates are: Batch 15496 (Exp. 4/30/2022), Batch 16347 (Exp. 1/31/2023) for 100g tubes; Batch 15496 (Exp. 4/30/2022) and Batch 16298 (Exp. 1/31/2023) for 60g and 15g tubes.

Patients and healthcare providers should stop using affected product. Consumers with questions should contact Teligent Pharma or consult their healthcare provider.

The recalled product

Product
Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical corticosteroid
Hazard
  • cgmp-violation
  • manufacturing-deviation

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 (7)

  • Batch: a) 15496
  • Exp. 4/30/2022
  • 16347
  • Exp. 1/31/2023
  • b) 15496
  • 16298
  • c) 15496

Distribution

Distributed nationwide across the United States.

Related recalls

Same category