Lidocaine Hydrochloride Topical Solution USP 4% recalled over manufacturing violations

Recall date

October 12, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teligent Pharma, Inc. recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena,…

Recall number

D-0281-2022

FDA classification

Class II

Brand / firm

Teligent Pharma, Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50