The Recall Desk
ModerateFDA (Drugs)·D-0699-2022·Announced 2022-03-30

Triamcinolone Acetonide Ointment Recalled Due to cGMP Deviations

Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% nationwide because the manufacturer is discontinuing its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation.

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 recall. The source text identifies cGMP deviations based on discontinuation of the stability study program, which is a regulatory/documentation issue rather than a reported safety incident. No illnesses, injuries, or specific product quality failures are reported in the source, making this a precautionary, compliance-based recall.

Plain-English summary

Teligent Pharma, Inc. is recalling Triamcinolone Acetonide Ointment USP, 0.1% in all dosage forms: 15-gram tubes (NDC 52565-014-15), 80-gram tubes (NDC 52565-014-80), and 1-pound jars (NDC 52565-014-26). A total of 482,003 tubes and 45,583 jars are affected. The product is distributed nationwide in the USA and Puerto Rico.

The recall is due to current Good Manufacturing Practice (cGMP) deviations. The firm is discontinuing its stability study program, which is required to ensure the product maintains its safety and efficacy throughout its shelf life.

Consumers who have this product should stop using it and consult with their pharmacist or healthcare provider. Patients should not stop taking their prescribed corticosteroid medication without medical guidance; they should contact their healthcare provider for alternative treatment options.

Specific batch numbers and expiration dates affected by this recall are listed in the FDA notice.

The recalled product

Product
Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
  • cgmp-deviation
  • stability-study-discontinuation

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 (20)

  • Batch: a) 15000
  • Exp. 1/31/2023
  • 15591
  • Exp. 4/30/2023
  • 15946
  • Exp. 9/30/2023
  • b) 14674
  • Exp. 11/30/2022
  • 14760
  • 14798
  • Exp. 12/31/2022
  • 14896
  • 15000
  • 15802
  • 15833
  • Exp. 7/31/2023
  • 15872
  • Exp. 8/31/2023
  • 16069
  • Exp. 10/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category