D-0014-2023 Class III Terminated
FDA drug recall D-0014-2023 was initiated by LNK International, Inc. on Oct 11, 2022 and is designated Class III. Reason for recall: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg The recall status is terminated (terminated Jul 25, 2023). Affected quantity: 66,384 boxes of twenty tablets each.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 26, 2022
- Initiation Date
- Oct 11, 2022
- Termination Date
- Jul 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66,384 boxes of twenty tablets each
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
Reason for Recall
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Distribution Pattern
Nationwide
Code Information
P129910 P129911 P130240
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0014-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026