Why it was recalled
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
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
Lot numbers, UPCs & expiration codes
P129910 P129911 P130240
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0014-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 11, 2022
- FDA report date
- Oct 26, 2022
- Quantity
- 66,384 boxes of twenty tablets each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LNK International, Inc.
Original FDA data
Every field from FDA enforcement report D-0014-2023, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90983
- Address
- 55 Arkay Dr
- Code information
- P129910 P129911 P130240
- Postal code
- 11788-3707
- Report date
- Oct 26, 2022
- Product type
- Drugs
- Recall number
- D-0014-2023
- Classification
- Class III
- Recalling firm
- LNK International, Inc.
- Product quantity
- 66,384 boxes of twenty tablets each
- Termination date
- Jul 25, 2023
- Reason for recall
- Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 11, 2022
- Initial firm notification
- Center classification date
- Oct 18, 2022