18 FDA recalls mention Levetiracetam. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Levetiracetam.
Reason LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is…
Reason Defective container: Customer complaints for oral solution leaking from bottles.
Reason Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Reason Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Reason Failed Dissolution Specifications.
Reason Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as…
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Presence of foreign substance (screw)
Reason Failed Dissolution Specifications: 6 month time point.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP…
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