Drug Enforcement D-0014-2023

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

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Status

Terminated

Classification

Class III

Report Date

October 26, 2022

Termination Date

July 25, 2023

Product Information

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
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
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
LNK International, Inc.
Address
55 Arkay Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0014-2023
Event ID
90983
Recall initiation date
October 11, 2022
Center classification date
October 18, 2022
Code info
P129910 P129911 P130240
More code info
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