D-1372-2020 Class III Terminated
FDA drug recall D-1372-2020 was initiated by American Health Packaging on June 10, 2020 and is designated Class III. Reason for recall: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. The recall status is terminated (terminated August 3, 2022). Affected quantity: 265 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- June 10, 2020
- Termination Date
- August 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 265 cartons
Product Description
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
Reason for Recall
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Distribution Pattern
Nationwide USA
Code Information
Lot #: 189551, Exp 04/30/2021