FDAClass IIJanuary 20, 2021

Levetiracetam Oral Solution recall

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

Why was Levetiracetam Oral Solution recalled?

Defective container: Customer complaints for oral solution leaking from bottles.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022

Product
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
Recalling firm
Akorn, Inc.
Quantity
22,248 bottles
Distribution
Nationwide in the USA and Puerto Rico
Recall date
January 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls