Recalling firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Product type
Drug
Status
Terminated
Report date
2025-02-12
Distribution
OH
Firm state
SC
Product quantity
4080 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
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
Code / lot info
Lot number 4B07, Exp Date: 2026-OCT-31
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.