LNK International, Inc.: Drug Recall

Recall #D-0665-2021 · 07/07/2021

Class III: Low Risk

Recall Details

Recall Number: D-0665-2021
Classification: Class III
Product Type: Drug
Recalling Firm: LNK International, Inc.
Status: Terminated
Date Initiated: 07/07/2021
Location: Hauppauge, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,472 bottles

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'

Product Description

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

Distribution Pattern

Distributed in PA

Other Recalls by LNK International, Inc.

Class II: Risk 11/14/2024

CGMP Deviations: Released product should have been rejected.
Class III: Low Risk 10/11/2022

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III: Low Risk 08/04/2022

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

View all recalls by LNK International, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.