Teva Recalls Nabumetone Tablets Due to Missing Labels and Leaflets
Teva Pharmaceuticals USA is recalling 576 bottles of Nabumetone 750 mg tablets because they lack required leaflets and approved labels.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging defect (missing labels/leaflets) rather than a direct safety hazard like contamination or mislabeling of active ingredients.
Plain-English summary
Teva Pharmaceuticals USA is recalling 576 bottles of Nabumetone Tablets USP, 750 mg, 100 count. The recall is due to the absence of required leaflets and approved labels on the bottles.
The affected product is identified by Lot # 05N533 with an expiration date of 11/16. The product was distributed nationwide and in Puerto Rico.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 576
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 05N533
- Exp 11/16
Distribution
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