← FDA ENFORCEMENT
D-0222-2025Class III

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

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 & Qualification
Reason 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
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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.