The Recall Desk
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.

What this means for you

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
  • cgmp-deviation
  • unverified-stability

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.

Related recalls

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