Key Takeaway

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. by Teligent Pharma, Inc. was recalled on July 29, 2021. The hazard: Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

FDA Drug Class III Terminated

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.

Recalled: July 29, 2021 ~114,456 tubes units affected D-0785-2021

Description

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.

Hazard / Reason

Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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.

Drugs

Company Information

Teligent Pharma, Inc.

Buena, NJ, United States

View all 63 recalls by Teligent Pharma, Inc. →

Distribution

Distributed Nationwide in the USA

Related Recalls

Frequently Asked Questions

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