FDA recall D-0014-2023

LNK International, Inc. · Class III · drug

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2022-10-11
Report date: 2022-10-26
Termination date: 2023-07-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2023