The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0683-2022·Announced 2022-03-30

Fluocinonide Cream Recalled for Manufacturing Compliance and Stability Deviations

Teligent Pharma, Inc. is recalling Fluocinonide Cream USP 0.1% due to manufacturing compliance deviations and discontinuation of stability studies. The recall affects products nationwide in the USA and Puerto Rico.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II drug recall involving manufacturing compliance deviations (discontinued stability studies). While no illnesses or injuries have been reported, the inability to verify product stability represents a potential risk of harm, placing this in the High category per the rubric.

Plain-English summary

Teligent Pharma, Inc. is recalling 13,905 tubes of Fluocinonide Cream USP, 0.1%, a prescription corticosteroid cream distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations. The manufacturer has discontinued its stability study program, which affects all unexpired products.

Affected batch numbers are 15288 (expires 3/31/2022), 16065 (expires 10/31/2022), 16430, 16431 (expires 2/28/2023), and 16675 (expires 3/31/2023). Those who have received this product should discontinue use.

The recalled product

Product
Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
13,905

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 (9)

  • Batch: 15288
  • Exp. 3/31/2022
  • 16065
  • Exp. 10/31/2022
  • 16430
  • 16431
  • Exp. 2/28/2023
  • 16675
  • Exp. 3/31/2023

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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