The Recall Desk
LowFDA (Drugs)·D-0787-2017·Announced 2017-05-24

Teligent Recalls Desoximetasone Ointment Due to Superpotent Drug Classification

Teligent, Inc. is voluntarily recalling 3,600 tubes of Desoximetasone Ointment 0.25% in Tennessee due to a superpotent drug classification.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Teligent, Inc. is voluntarily recalling 3,600 tubes of Desoximetasone Ointment USP, 0.25%, 15 g tubes. The product is identified by NDC 52565-030-15, Lot # 5760, and an expiration date of 5/31/2018. The recall was initiated on April 7, 2017, and the status is currently terminated.

The reason for the recall is that the product is classified as a "Superpotent Drug." The FDA has assigned this recall a Class III classification, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was initiated by the firm and is voluntary.

The affected product was distributed in Tennessee (TN). Consumers and healthcare providers who have this specific lot of Desoximetasone Ointment should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15
Manufacturer
Teligent, Inc.
Category
Drug — Topical Steroid
Hazard
Affected units
3,600

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)

  • Lot #: 5760
  • Exp. 5/31/2018

Distribution

Distributed in 1 state:

Related recalls

Same hazard · superpotent drug

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