Reported Feb 12, 2025 · Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI…
PAI Holdings, LLC. dba Pharmaceutical Associates Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PAI Holdings, LLC. dba Pharmaceutical Associates Inc · 1700 Perimeter Rd · Greenville, SC · 29605-5252
Is this the product you have?
- 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 codes and dates
- Lot number 4B07
- Exp Date2026-OCT-31
- Amount recalled
- 4080 Bottles
Where it was sold
Why it was recalled
Superpotent; sodium benzoate preservative
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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