Gentamicin Sulfate Cream Recalled Due to Manufacturing Practice Violations
Teligent Pharma, Inc. is recalling 31,489 tubes of Gentamicin Sulfate Cream (0.1%) nationwide due to manufacturing violations. The company discontinued its stability testing program without proper authorization.
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: FDA Class II recall with no reported illnesses or injuries. The hazard—discontinuation of required stability testing—is a manufacturing compliance issue rather than a confirmed product contamination or defect. This type of voluntary precautionary recall based on process deviations is classified as Moderate.
Plain-English summary
Teligent Pharma, Inc. has recalled Gentamicin Sulfate Cream USP 0.1% (NDC 70512-036-30), a prescription topical antibiotic manufactured for SOLA Pharmaceuticals, LLC, due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, which is required to ensure the product remains safe and effective throughout its shelf life.
The recall affects approximately 31,489 tubes distributed nationwide in the United States and Puerto Rico. The affected batches are Batch 15725 (expiration 6/30/2022) and Batch 16113 (expiration 10/31/2022). All products within their expiration dates are being recalled.
The recalled product
- Product
- Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Antibiotic
- Hazard
- cgmp-deviation
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 (4)
- Batch: 15725
- Exp. 6/30/2022
- 16113
- Exp. 10/31/2022
Distribution
Distributed nationwide across the United States.
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