Recalls / Class III
Class IIID-1372-2020
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
- Affected lot / code info
- Lot #: 189551, Exp 04/30/2021
Why it was recalled
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 265 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2020-06-10
- FDA classified
- 2020-07-01
- Posted by FDA
- 2020-07-01
- Terminated
- 2022-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1372-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.