The Recall Desk
ModerateFDA (Drugs)·D-0686-2022·Announced 2022-03-30

Gentamicin Sulfate Cream USP 0.1% Recalled for cGMP Deviations

Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% distributed nationwide because the manufacturer is discontinuing its stability study program, which represents a deviation from FDA good manufacturing practices (cGMP).

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 for cGMP deviations related to discontinued stability testing. The source text does not report any illnesses, injuries, or safety incidents. This is a compliance-based recall with no known harm reported, making it a precautionary measure appropriate for a Moderate severity classification.

Plain-English summary

Teligent Pharma, Inc. is recalling all unexpired batches of Gentamicin Sulfate Cream USP, 0.1%, packaged in 15 g tubes (NDC 52565-085-15) and 30 g tubes (NDC 52565-085-30). The recall was initiated because the firm is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practices (cGMP) requirements.

The recalled product has been distributed nationwide in the USA and Puerto Rico. Affected batches include: 15342, 15343, 16686 (exp. 3/31/2023); 15259, 15260 (exp. 3/31/2022); 15282 (exp. 4/30/2022); 15283 (exp. 5/31/2022); 15725, 15745, 15764 (exp. 6/30/2022); and 16066 (exp. 10/31/2022). The total number of tubes recalled is 355,672.

Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider for alternative treatment. Patients should not discard the medication without consulting their pharmacist or healthcare provider about proper disposal instructions.

The recalled product

Product
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Antibiotic Cream
Hazard
  • cgmp-deviation
  • stability-testing-discontinued

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 (17)

  • Batch: a) 15342
  • 15343
  • 16686
  • Exp. 3/31/2023
  • b) 15259
  • 15260
  • Exp. 3/31/2022
  • 15282
  • Exp. 4/30/2022
  • 15283
  • Exp. 5/31/2022
  • 15725
  • 15745
  • 15764
  • Exp. 6/30/2022
  • 16066
  • Exp. 10/31/2022

Distribution

Distributed nationwide across the United States.

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