The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0687-2022·Announced 2022-03-30

Gentamicin Sulfate Ointment Recalled Due to cGMP Deviations

Teligent Pharma is recalling all unexpired batches of Gentamicin Sulfate Ointment USP 0.1% due to cGMP deviations related to discontinuation of the firm's 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 involving a manufacturing practice deviation. The source text does not report any illnesses, injuries, or deaths related to use of the product, and the hazard is procedural rather than a direct safety threat to end users. Per the rubric, Class II recalls without reported hospitalization constitute a Moderate severity level.

Plain-English summary

Teligent Pharma, Inc. is recalling Gentamicin Sulfate Ointment USP 0.1% in 15-gram tubes (NDC 52565-090-15) and 30-gram tubes (NDC 52565-090-30). The recall affects 43,956 tubes distributed nationwide in the USA and Puerto Rico.

The recall is due to cGMP (current good manufacturing practice) deviations. The firm is discontinuing its stability study program, which affects all products within their expiration dates.

Consumers who have received this medication should consult their healthcare provider or pharmacist regarding their use of the product. Healthcare providers and patients should not abruptly discontinue use without medical guidance.

The recalled product

Product
Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Ointment
Hazard
Affected units
43,956

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 (5)

  • Batch: a) 16878
  • 16912
  • Exp. 5/31/2023
  • b)16878
  • Exp. 5/21/2023

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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