Erythromycin Topical Gel Recalled for Failed Impurity Specifications
Teligent Pharma is recalling one lot of Erythromycin Topical Gel USP 2% because the product failed to meet specifications for unknown maximum related compounds.
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. The source text does not report any illnesses or injuries, and the hazard is based on failed specifications for an unidentified impurity or degradation product, making this a precautionary recall without known harm. This fits the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Teligent Pharma, Inc. is recalling Erythromycin Topical Gel USP, 2%, in 30-gram tubes (Lot 15724, expiration 06/2022, NDC 63739-053-66) distributed nationwide by McKesson Corporation. The recall was initiated because the lot did not meet specification for unknown maximum related compounds, a measure of impurities or degradation in the product.
A total of 11,040 tubes were distributed in the United States. Healthcare providers and patients who have received this product should stop using it and contact their healthcare provider for guidance.
Consumers with questions about this recall should contact the manufacturer at the address provided: Teligent Pharma, Inc., Buena, NJ 08310.
The recalled product
- Product
- Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Antibiotic
- Hazard
- impurity
- degradation
- failed-specification
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: 15724
- Exp. 06/2022
Distribution
Distributed nationwide across the United States.
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