The Recall Desk
ModerateFDA (Drugs)·D-0752-2021·Announced 2021-08-25

Triamcinolone Acetonide Ointment Mispack Recall by Teligent Pharma

Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% due to a labeling mispack affecting Lot #16630 with expiration 03/2023. The recall was issued due to incorrect labeling on the product.

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 involving a labeling/packaging mispack issue with no reported illnesses or injuries. The hazard is a labeling discrepancy rather than a product defect or contamination, which aligns with the Moderate severity category for labeling errors.

Plain-English summary

Teligent Pharma, Inc., located in Buena, New Jersey, is recalling Triamcinolone Acetonide Ointment USP 0.1%, 80 g cartons (NDC 52565-014-80), packaged in tubes. The specific lot affected is Lot #16630 with an expiration date of March 2023. The recall was initiated due to a correct labeled product mispack.

This is a nationwide distribution recall. Consumers who have received this product should be aware of the mispack issue and may wish to contact their healthcare provider or pharmacist for guidance on whether their medication is affected or if replacement is needed.

The recalled product

Product
Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
  • mislabeling
  • mispack

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 (2)

  • Lot # 16630
  • Exp 03/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category