Erythromycin Topical Solution Recalled for Defective Container Seal
Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL bottles) due to defective containers that may lack seal integrity, potentially allowing contamination or leakage.
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 recall is FDA Class II with no reported illnesses or injuries. The defect is a packaging/container integrity issue that poses a potential quality risk but no specific harm has been documented. This falls under the Moderate category for labeling or container defects without confirmed adverse events.
Plain-English summary
Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP, 2%, in 60 mL bottles nationwide due to a defective container issue. The recalled product may have containers with compromised seal integrity.
The recalled medication is Erythromycin Topical Solution USP, 2%, 60 mL bottle, NDC 52565-027-59, manufactured by Teligent Pharma, Inc. of Buena, New Jersey. The affected lot is Lot #14892 with an expiration date of January 2022. Approximately 7,488 bottles have been distributed nationwide.
Lack of seal integrity can allow the product to become contaminated or may result in leakage, compromising the quality and safety of the medication. Consumers who have this product should contact their pharmacy or healthcare provider for guidance on whether their specific medication is affected.
The recalled product
- Product
- Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Antibiotic
- Affected units
- 7,488
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 #: 14892
- Exp 1/2022
Distribution
Distributed nationwide across the United States.
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