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Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manu...

FDA Recall #D-0846-2022 — Class III — April 15, 2022

Recall #D-0846-2022 Date: April 15, 2022 Classification: Class III Status: Terminated

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

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

66,744 bottles

Distribution

Nationwide USA and Puerto Rico

Code Information

Lot #: 370978, Exp 9/30/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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