July 2021 FDA Recall Drug by Lnk International, Inc.
D-0665-2021 - Labeling

This Class III drug recall was voluntarily initiated by Lnk International, Inc. on July 7, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Distributed in PA and the recall is currently terminated.

Recall Number: D-0665-2021

Reason for Recall
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Initiated
07-07-2021
Reported
07-28-2021
Quantity
8,472 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88244
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
LNK International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-04-2023
Product Description About Product Description
Full technical description of the product.
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

Batch or Lot Expiration Information

Lot# P120999, Exp 07/31/2022