Class III · Low risk
Nabumetone Tablets
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
NABUMETONE Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Drug: Nabumetone
- Recalling firm
- Teva Pharmaceuticals USA
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0773-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nabumetone recalls
See all
Class II · Moderate risk
Nabumetone
Labeling: Label Mixup: NABUMETONE, Tablet, 500 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD46429_1, EXP: 5/15/2014.
Other recalls by Teva Pharmaceuticals USA
All 2015 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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