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
D-0014-2023
Product summary
- Event
- Event 90983
- Status
- Terminated
- Classification
- Class III
- Quantity
- 66,384 boxes of twenty tablets each
- Official record key
drug-enforcement:D-0014-2023
Official wording
Reason: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Code information: P129910 P129911 P130240
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled