FDAFDA · Food and drugs·Recall number D-0221-2021
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
Published January 20, 2021 · Recall initiated: December 28, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container: Customer complaints for oral solution leaking from bottles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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