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.
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 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
- 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 (5)
- Batch: a) 16878
- 16912
- Exp. 5/31/2023
- b)16878
- Exp. 5/21/2023
Distribution
Distributed nationwide across the United States.
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