The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0695-2022·Announced 2022-03-30

Nystatin and Triamcinolone Acetonide Ointment Recall Due to cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Nystatin and Triamcinolone Acetonide Ointment (15g, 30g, and 60g tubes) nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.

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 2/5 (Moderate).

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) that creates theoretical risk but is not associated with documented patient harm. The precautionary nature and lack of reported adverse events place this in the Moderate category.

Plain-English summary

Teligent Pharma, Inc. is recalling Nystatin and Triamcinolone Acetonide Ointment, USP in three package sizes: 15-gram tubes (NDC 52565-042-15), 30-gram tubes (NDC 52565-042-30), and 60-gram tubes (NDC 52565-042-60). The recall affects approximately 217,184 tubes distributed nationwide in the USA and Puerto Rico.

The recall is being 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 the recall.

Patients taking this medication should consult their healthcare provider or pharmacist before stopping use. Consumers with affected product should contact their pharmacy or healthcare provider for guidance on obtaining replacement medication or alternative treatment options.

The recalled product

Product
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Ointment
Hazard
Affected units
217,184

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) 15125
  • Exp. 2/28/2022
  • 15385
  • Exp. 3/31/2022
  • 15613
  • Exp. 5/31/2022
  • 16027
  • Exp. 9/30/2022
  • 16204
  • Exp. 11/30/2022
  • 16376
  • Exp. 1/31/2023
  • 16707
  • Exp. 3/31/2023
  • b) 15385
  • 15752
  • Exp. 6/30/2022
  • 15346
  • 16188
  • 16567

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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