PlainRecalls
FDA Drug Low 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.

Reported: September 8, 2021 Initiated: July 29, 2021 #D-0785-2021

Product 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.

Reason for Recall

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

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
114,456 tubes
Distribution
Distributed Nationwide in the USA
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
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 by Teligent Pharma, Inc.. Units affected: 114,456 tubes.
Why was this product recalled?
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 8, 2021. Severity: Low. Recall number: D-0785-2021.