Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
Compare with the code on your package — it is the most precise check available.
Drug: Levetiracetam
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Levetiracetam NDC 65862-0247 |
750 mg/1 | Tablet, Film Coated | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Defective container: Customer complaints for oral solution leaking from bottles.
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
shortfill; reports of empty capsules.
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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