Recall Enforment Report D-0222-2025

Drug Recall Enforcement Report Class III voluntary initiated by PAI Holdings, LLC. dba Pharmaceutical Associates Inc, originally initiated on 01-07-2025 for 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 The product was recalled due to superpotent; sodium benzoate preservative. The product was distributed in Oh and the recall is currently ongoing.

Field Name	Field Value
Event ID	96119 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0222-2025 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	OH What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Superpotent; sodium benzoate preservative What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4080 Bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	02-12-2025
Recall Initiation Date	01-07-2025 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Code Info	Lot number 4B07, Exp Date: 2026-OCT-31 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0121-0775-04; 0121-0775-08; 0121-0775-16; 0121-1775-05; 0121-1775-00; 0121-1775-10; 0121-1775-40; 0121-1550-10; 0121-1550-00; 0121-1550-40
Status	Ongoing

Recalled Products