Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

FDA recall notice · announced December 25, 2019 · Lannett

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80

Reason for recall

Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 2190A, 2191A, Exp. Date 07/2021
Quantity: 16,668 bottles
Status: Terminated
Products in this recall event:
- Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80 (D-0630-2020)

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