FDA recall D-0296-2022

Product

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64

Reason for recall

Superpotent Drug: Minimally superpotent

Distribution

Distributed to a wholesaler in CO who further distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2021-11-30

Report date

2022-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buena, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2022