Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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.
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