Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective container: Customer complaints for oral solution leaking from bottles.
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
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 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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.