Why it was recalled
Incorrect/Undeclared Excipient: Product contains alcohol
Product description
Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
IL only
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-0787-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 29, 2022
- FDA report date
- May 4, 2022
- Quantity
- 40000 - 50000 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AptaPharma Inc.
Original FDA data
Every field from FDA enforcement report D-0787-2022, exactly as published.
Show all FDA fields
- City
- Pennsauken
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89905
- Address
- 1533 Union Ave
- Code information
- All lots
- Postal code
- 08110-2489
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0787-2022
- Classification
- Class III
- Recalling firm
- AptaPharma Inc.
- Product quantity
- 40000 - 50000 units
- Termination date
- Apr 24, 2024
- Reason for recall
- Incorrect/Undeclared Excipient: Product contains alcohol
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.
- Distribution pattern
- IL only
- Recall initiation date
- Mar 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2022