Recalls / Class III
Class IIID-0014-2023
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
- Brand name
- Sinus Pressure, Pain And Cough
- Generic name
- Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
- Active ingredients
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Route
- Oral
- NDC
- 0363-6171
- FDA application
- M012
- Affected lot / code info
- P129910 P129911 P130240
Why it was recalled
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Recalling firm
- Firm
- LNK International, Inc.
- Manufacturer
- Walgreen Company
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 55 Arkay Dr, N/A, Hauppauge, New York 11788-3707
Distribution
- Quantity
- 66,384 boxes of twenty tablets each
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2022-10-11
- FDA classified
- 2022-10-18
- Posted by FDA
- 2022-10-26
- Terminated
- 2023-07-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0014-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.