Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO.,...
FDA Recall #D-0221-2021 — Class II — December 28, 2020
Product Description
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
Reason for Recall
Defective container: Customer complaints for oral solution leaking from bottles.
Recalling Firm
Akorn, Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
22,248 bottles
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated