The Recall Desk
ModerateFDA (Drugs)·D-0684-2022·Announced 2022-03-30

Fluocinonide Gel Recalled for Manufacturing Process Deviations

Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP 0.05% nationwide within expiration date due to manufacturing deviations related to discontinued stability studies.

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 precautionary recall due to cGMP deviations and the firm's discontinuation of stability studies. No illnesses or injuries have been reported. Per the rubric, voluntary precautionary recalls are scored as Moderate.

Plain-English summary

Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP, 0.05%, that remain within their expiration dates. The product is packaged in 15 g, 30 g, and 60 g tubes under three NDC numbers. The recall is due to current Good Manufacturing Practice (cGMP) deviations: the manufacturing firm is discontinuing its stability study program for this product.

The affected product was distributed nationwide in the USA and Puerto Rico. A total of 51,748 tubes are subject to this recall.

Consumers who have this product should discontinue use and consult their healthcare provider regarding alternative treatment options. Affected patients should follow Teligent Pharma's instructions for product return and disposal.

The recalled product

Product
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
51,748

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 (8)

  • Batch: a) 15122
  • Exp. 2/28/2022
  • 15475
  • Exp. 3/31/2022
  • b) 15119
  • 15122
  • 15380
  • c) 15380

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 →

Related recalls

Same manufacturer · Teligent Pharma, Inc.

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Same hazard · stability issue

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