October 2022 FDA Recall Sinus Pressure, Pain And Cough by Lnk International, Inc.
D-0014-2023 - Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

This Class III drug recall was voluntarily initiated by Lnk International, Inc. on October 11, 2022 for the product Sinus Pressure, Pain And Cough. The FDA reported the reason for recall as boxes mislabeled to read "decongestant free", but the product contains phenylephrine hci 5mg. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0014-2023

Reason for Recall
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Initiated
10-11-2022
Reported
10-26-2022
Quantity
66,384 boxes of twenty tablets each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90983
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-25-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# P129910 P129911 P130240

Affected Packages Involved in this Recall

0363-6171-09 Sinus Pressure, Pain And Cough