Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical
Summary
The FDA issued a Class III for Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl by PAI Holdings, LLC. dba Pharmaceutical Associates Inc. Reason: Superpotent; sodium benzoate preservative.
Details
Source
Drug Recall
External ID
D-0222-2025
Action Date
2025-02-12
Status
Completed
Category
drug
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/Code Info: Lot number 4B07, Exp Date: 2026-OCT-31
Quantity Affected: 4080 Bottles
Reason for Recall
Superpotent; sodium benzoate preservative
Distribution
OH
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-07
Company
Greenville, SC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PAI Holdings, LLC. dba Pharmaceutical Associates Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PAI Holdings, LLC. dba Pharmaceutical Associates Inc have FDA actions?
PAI Holdings, LLC. dba Pharmaceutical Associates Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0222-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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