Recalls / Class III
Class IIID-0222-2025
Product
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
- Brand name
- Guaifenesin And Codeine Phosphate
- Generic name
- Guaifenesin And Codeine Phosphate
- Active ingredients
- Codeine Phosphate, Guaifenesin
- Route
- Oral
- NDCs
- 0121-0775, 0121-1775, 0121-1550
- FDA application
- M012
- Affected lot / code info
- Lot number 4B07, Exp Date: 2026-OCT-31
Why it was recalled
Superpotent; sodium benzoate preservative
Recalling firm
- Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Manufacturer
- PAI Holdings, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Perimeter Rd, Greenville, South Carolina 29605-5252
Distribution
- Quantity
- 4080 Bottles
- Distribution pattern
- OH
Timeline
- Recall initiated
- 2025-01-07
- FDA classified
- 2025-02-04
- Posted by FDA
- 2025-02-12
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0222-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.