Sinus Pressure, Pain And Cough Tablet, Film Coated
FDA Recall NDC 0363-6171
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sinus Pressure, Pain And Cough (NDC 0363-6171). A significant event, classified as Class III, was initiated on Oct 11, 2022 by Walgreen Company. The reported reason for this action was: "Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2022 Class III Recall: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Recall Number
Class III Terminated
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Oct 11, 2022
Oct 26, 2022
66,384 boxes of twenty tablets each
Recall Profile & Regulatory Data
Event ID
90983
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LNK International, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 25, 2023
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
Batch or Lot Expiration Information
Lot# P129910 P129911 P130240
Affected Packages Involved in this Recall
0363-6171-09Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
