FDA recall D-0846-2022

Akorn, Inc. · Class III · drug

Product

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

Reason for recall

Failed viscosity specification - product was below specificcation

Distribution

Nationwide USA and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2022-04-15
Report date: 2022-05-11
Termination date: 2023-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0846-2022