Nabumetone Tablets Recalled for Missing Medication Guide Labeling
American Health Packaging is recalling 265 cartons of Nabumetone Tablets because the carton label did not include the required statement to dispense with the accompanying Medication Guide.
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/labeling defect rather than a direct physical hazard.
Plain-English summary
American Health Packaging is recalling 265 cartons of Nabumetone Tablets, USP, 500 mg. The product is distributed nationwide in the United States. The specific lot number is 189551, with an expiration date of 04/30/2021.
The recall was initiated due to a labeling error. The statement "Pharmacist: Dispense with the accompanying Medication Guide" was not included on the carton label. This omission means that pharmacists may not be prompted to provide the required Medication Guide to patients at the time of dispensing.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 265
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 #: 189551
- Exp 04/30/2021
Distribution
Distributed nationwide across the United States.
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