LEVETIRACETAM

Generic: LEVETIRACETAM

Prasco LaboratoriesManufacturer
ORALRoute
LEVETIRACETAMActive Substance
2015-07-31Original Approval

LEVETIRACETAM is FDA application NDA207958, sponsored by APRECIA PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2018-03-27
Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distrib

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t

Class II2018-03-27
Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distribute

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t

Class I2025-03-13
Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chl

Class II2017-10-12
Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber P

Presence of foreign substance (screw)

Class II2020-03-18
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Class I2018-10-26
Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL In

Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the

Class II2018-03-27
Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distribu

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between t

Class II2012-07-27
Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, W

Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign ta

Top Reported Reactions

1
DRUG INEFFECTIVE
9,025 reports
2
SEIZURE
8,868 reports
3
OFF LABEL USE
6,474 reports
4
MATERNAL EXPOSURE DURING PREGNANCY
3,115 reports
5
EPILEPSY
2,783 reports
6
FOETAL EXPOSURE DURING PREGNANCY
2,537 reports
7
DRUG INTERACTION
2,485 reports
8
FATIGUE
2,464 reports
9
CONDITION AGGRAVATED
2,291 reports
10
SOMNOLENCE
2,094 reports