June 2020 FDA Recall Drug by American Health Packaging
D-1372-2020 - Labeling Not Elsewhere Classified
This Class III drug recall was voluntarily initiated by American Health Packaging on June 10, 2020 for the product Drug. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1372-2020
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
06-10-2020
07-01-2020
265 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
08-03-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 189551, Exp 04/30/2021
