Erythromycin Topical Gel 2% Recalled Due to Failed Impurity Specifications
Teligent Pharma, Inc. is recalling Erythromycin Topical Gel 2% due to failed impurities and degradation specifications. The recall affects approximately 22,824 tubes distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III recall for a manufacturing/specification defect with no reported illnesses or injuries mentioned in the source. Per the rubric, FDA Class III recalls are typically scored 1 or 2; the specification failure (impurities and degradation) represents a quality control issue warranting a Moderate score rather than Low.
Plain-English summary
Teligent Pharma, Inc. is recalling Erythromycin Topical Gel 2% in 30 g and 60 g tubes due to failed impurities and degradation specifications.
The affected products are: - Erythromycin Topical Gel 2%, 30 g (NDC 52565-033-30), Lot 14010, Exp July 2021 - Erythromycin Topical Gel 2%, 60 g (NDC 52565-033-60), Lot 13865, Exp June 2021 and Lot 14011, Exp July 2021
Approximately 22,824 tubes have been distributed nationwide. The product is manufactured by Teligent Pharma, Inc. in Buena, NJ.
Consumers should discontinue use of the recalled product. Healthcare providers and patients with questions should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Antibiotic
- Affected units
- 22,824
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 (6)
- 1) NDC 52565-033-30 Lot 14010
- Exp July 2021
- 2) NDC 52565-033-60 Lot 13865
- Exp June 2021
- Lot 14011
- Exp July 2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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