The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0681-2022·Announced 2022-03-30

Diflorasone Diacetate Ointment recalled due to discontinued stability studies

Teligent Pharma is recalling all unexpired Diflorasone Diacetate Ointment 0.05% due to cGMP deviations. The company discontinued its stability study program, preventing verification that the product maintains safety and effectiveness throughout shelf life.

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 an FDA Class II recall for cGMP deviations affecting a pharmaceutical product whose stability cannot be verified through discontinued studies. While no illnesses or injuries have been reported, the inability to confirm product stability throughout its shelf life represents a risk-of-harm situation meeting the Score 3 criterion.

Plain-English summary

Teligent Pharma, Inc. is recalling all unexpired tubes of Diflorasone Diacetate Ointment USP, 0.05% (60 g tubes, NDC 70512-031-60), manufactured for SOLA Pharmaceuticals, LLC. The recall is due to current Good Manufacturing Practice (cGMP) deviations: the firm has discontinued its stability study program. Without ongoing stability studies, the company cannot verify that the product maintains its potency, safety, and quality throughout its labeled expiration date.

The recall affects 24,304 bottles distributed nationwide in the United States and Puerto Rico. The affected batches include: Batch 15800 (expiration 7/31/2022); Batches 15876, 15904, 15917, and 15922 (expiration 8/31/2022); and Batches 16202 and 16203 (expiration 11/30/2022).

Consumers who have this product should stop using it and consult their healthcare provider or pharmacist. Return the product to the pharmacy or place of purchase. To date, no adverse events have been reported related to this recall.

The recalled product

Product
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
24,304

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 (10)

  • Batch: 15800
  • Exp. 7/31/2022
  • 15876
  • 15904
  • 15917
  • 15922
  • Exp. 8/31/2022
  • 16202
  • 16203
  • Exp. 11/30/2022.

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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