PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: May 11, 2022 Initiated: April 15, 2022 #D-0846-2022

Product Description

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

Details

Recalling Firm
Akorn, Inc.
Units Affected
66,744 bottles
Distribution
Nationwide USA and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 66,744 bottles.
Why was this product recalled?
Failed viscosity specification - product was below specificcation
Which agency issued this recall?
This recall was issued by the FDA Drug on May 11, 2022. Severity: Low. Recall number: D-0846-2022.