The Recall Desk
ModerateFDA (Drugs)·D-0697-2022·Announced 2022-03-30

Triamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation

Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.

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 with no reported illnesses or injuries. The hazard is regulatory (cGMP deviation and lack of stability data) rather than a direct safety threat. The source text does not state that the product is unsafe or contaminated, only that the manufacturer has discontinued required testing procedures.

Plain-English summary

Triamcinolone Acetonide Cream USP, 0.1% — manufactured by Teligent Pharma, Inc. in Buena, New Jersey — is being recalled nationwide in the USA and Puerto Rico. The recall affects all product within expiry across four package sizes: 15-gram tubes (NDC 52565-056-15), 30-gram tubes (NDC 52565-056-30), 80-gram tubes (NDC 52565-056-80), and 1-pound jars (NDC 52565-056-26). Approximately 721,225 tubes and 90,893 jars are affected.

The recall is due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program. Stability studies are required to demonstrate that a drug maintains its identity, strength, quality, and purity throughout its shelf life.

Consumers should stop use and consult their healthcare provider or pharmacist before discarding or returning the product. This is a Class II recall issued by the FDA under recall number D-0697-2022.

The recalled product

Product
Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid Cream
Hazard
  • cgmp-deviation
  • stability-data-missing

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) 15123
  • Exp. 2/28/2022
  • 15875
  • Exp. 8/31/2022
  • 16115
  • Exp. 10/31/2022
  • b) 15123
  • 15201
  • 15477
  • Exp. 4/30/2022
  • 15897
  • 16090
  • 16374
  • Exp. 1/31/2023
  • 16676
  • Exp. 3/31/2023
  • 17109
  • Exp. 7/31/2023
  • c) 15241
  • 16610

Distribution

Distributed nationwide across the United States.

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