Guaifenesin And Codeine Phosphate Solution
FDA Recall NDC 0121-0775
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Guaifenesin And Codeine Phosphate (NDC 0121-0775). A significant event, classified as Class III, was initiated on Jan 07, 2025 by Pai Holdings, Llc. The reported reason for this action was: "Superpotent; sodium benzoate preservative"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Superpotent; sodium benzoate preservative
Jan 07, 2025
Feb 12, 2025
4080 Bottles
Recall Profile & Regulatory Data
Event ID
96119
Classification
Class III
Enforcement Status
Completed
Recalling Firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH
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
Batch or Lot Expiration Information
Lot# Lot number 4B07, Exp Date: 2026-OCT-31
Affected Packages Involved in this Recall
0121-0775-04Product
0121-0775-08Product
0121-0775-16Product
0121-1775-05Product
0121-1775-00Product
0121-1775-10Product
0121-1775-40Product
0121-1550-10Product
0121-1550-00Product
0121-1550-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
