Teligent Pharma Recalls Lidocaine Ointment for Failed Stability Specifications
Teligent Pharma is recalling Lidocaine Ointment USP, 5%, due to failed viscosity specifications. The recall covers 62,040 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a failed viscosity specification, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling of allergens.
Plain-English summary
Teligent Pharma, Inc. is recalling Lidocaine Ointment USP, 5%, in 35.44 g tubes. The recall was initiated because the product failed to meet stability specifications, specifically regarding viscosity results.
The affected product is identified by Lot 13269 with an expiration date of March 2021. A total of 62,040 tubes were distributed nationwide in the United States. The product is a prescription-only medication manufactured by Teligent Pharma, Inc., located in Buena, New Jersey.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Anesthetic
- Affected units
- 62,040
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 13269
- Exp March 2021
Distribution
Distributed nationwide across the United States.
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