FDA recall D-0221-2021

Akorn, Inc. · Class II · drug

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

Reason for recall

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

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2020-12-28
Report date: 2021-01-20
Termination date: 2022-08-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0221-2021