LNK International, Inc.: Drug Recall

Recall #D-0014-2023 · 10/11/2022

Class III: Low Risk

Recall Details

Recall Number: D-0014-2023
Classification: Class III
Product Type: Drug
Recalling Firm: LNK International, Inc.
Status: Terminated
Date Initiated: 10/11/2022
Location: Hauppauge, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 66,384 boxes of twenty tablets each

Reason for Recall

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

Product Description

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com

Distribution Pattern

Nationwide

Other Recalls by LNK International, Inc.

Class II: Risk 11/14/2024

CGMP Deviations: Released product should have been rejected.
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.
Class III: Low Risk 07/07/2021

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'

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.