Home / Recalls / Akorn, Inc. / D-0846-2022

D-0846-2022 Class III Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0846-2022 was initiated by Akorn, Inc. on Apr 15, 2022 and is designated Class III. Reason for recall: Failed viscosity specification - product was below specificcation The recall status is terminated (terminated Sep 28, 2023). Affected quantity: 66,744 bottles.

Recall Details

Product Type: Drugs
Report Date: May 11, 2022
Initiation Date: Apr 15, 2022
Termination Date: Sep 28, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 66,744 bottles

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

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Lot #: 370978, Exp 9/30/2022

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0846-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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