The Recall Desk
ModerateFDA (Drugs)·D-0698-2022·Announced 2022-03-30

Triamcinolone Acetonide Lotion Recalled for cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Triamcinolone Acetonide Lotion USP 0.025% due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.

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 a manufacturing practice deviation (discontinuation of stability studies), which is a precautionary compliance issue rather than an immediate documented health threat.

Plain-English summary

Teligent Pharma, Inc., of Buena, New Jersey, is recalling Triamcinolone Acetonide Lotion USP, 0.025%, supplied in 60 mL (60 grams) bottles, NDC 52565-010-59. The recall affects approximately 112,769 bottles distributed nationwide in the USA and Puerto Rico.

The recall is issued because the firm is discontinuing its stability study program, which constitutes a deviation from current Good Manufacturing Practice (cGMP) standards. All products within their expiration dates are included in this recall.

Affected batches include: 14796 (Exp. 12/31/2022), 14797 (Exp. 1/31/2023), 14534, 15571, 15572 (Exp. 4/30/2023), 15746, 15756 (Exp. 6/30/2023), 15982 (Exp. 9/30/2023), 16043, 16144, 16149 (Exp. 10/31/2023), 16433, 16434 (Exp. 2/29/2024), 16656, 16679 (Exp. 3/31/2024), and 16784 (Exp. 5/31/2024).

Patients and healthcare providers should discontinue use of affected batches and consult with their healthcare provider regarding alternative treatment options. The product is prescription-only (Rx only).

The recalled product

Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Steroid
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: 14796
  • Exp. 12/31/2022
  • 14797
  • Exp. 1/31/2023
  • 14534
  • 15571
  • 15572
  • Exp. 4/30/2023
  • 15746
  • 15756
  • Exp. 6/30/2023
  • 15982
  • Exp. 9/30/2023
  • 16043
  • 16144
  • 16149
  • Exp. 10/31/2023
  • 16433
  • 16434
  • Exp. 2/29/2024

Distribution

Distributed nationwide across the United States.

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