Why it was recalled
Superpotent; sodium benzoate preservative
Product description
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
Lot numbers, UPCs & expiration codes
Lot number 4B07, Exp Date: 2026-OCT-31
Where it was sold
OH
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-0222-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 7, 2025
- FDA report date
- Feb 12, 2025
- Quantity
- 4080 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Original FDA data
Every field from FDA enforcement report D-0222-2025, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 96119
- Address
- 1700 Perimeter Rd
- Code information
- Lot number 4B07, Exp Date: 2026-OCT-31
- Postal code
- 29605-5252
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0222-2025
- Classification
- Class III
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Product quantity
- 4080 Bottles
- Termination date
- Jul 25, 2026
- Reason for recall
- Superpotent; sodium benzoate preservative
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16
- Distribution pattern
- OH
- Recall initiation date
- Jan 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2025