January 2025 FDA Recall Guaifenesin And Codeine Phosphate by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc
D-0222-2025 - Superpotent; sodium benzoate preservative
This Class III drug recall was voluntarily initiated by Pai Holdings, Llc. Dba Pharmaceutical Associates Inc on January 7, 2025 for the product Guaifenesin And Codeine Phosphate. The FDA reported the reason for recall as superpotent; sodium benzoate preservative. The product was distributed in OH and the recall is currently completed.
Recall Number: D-0222-2025
Superpotent; sodium benzoate preservative
01-07-2025
02-12-2025
4080 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
