Teligent Pharma, Inc. recalls Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Phar
Recalled December 22, 2021 · FDA recall D-0279-2022 · Teligent Pharma
Hazard
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. · FDA Class II
Units
7,008 glass bottles
Sold at
Nationwide within the United States
Description
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.
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
Manufacturer(s)
Teligent Pharma, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →