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

FDA recall notice · announced January 20, 2021 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022
Quantity: 22,248 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0221-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.