Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications
Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a specification failure (viscosity) with no reported illnesses, injuries, or direct risk of harm. The hazard is a manufacturing specification deviation without evidence of adverse patient outcome, meeting the criterion for a Low severity classification.
Plain-English summary
Teligent Pharma, Inc. is recalling Lidocaine Ointment USP, 5% Rx Only, packaged in laminate tubes with a net weight of 35.44 g (1 1/4 oz). The affected product has National Drug Code (NDC) 52565-008-14 and includes Lot #15378 (expiration 3/2023) and Lot #14418 (expiration 10/2021). A total of 114,456 tubes have been distributed nationwide in the USA.
The recall was initiated because certain lots of this product do not meet the specification for viscosity, as determined through routine testing.
Consumers who have received or possess affected lots of this product should contact their healthcare provider or pharmacist for guidance. The product should not be used.
The recalled product
- Product
- Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
- specification-failure
- viscosity-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 (3)
- Lot #: 15378
- Exp 3/2023
- 14418 EXP 10/2021
Distribution
Distributed nationwide across the United States.
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