Product Detail

Product Description AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
Recall Number D-512-2013

Classification Class II

Code Info Lot # 11D001 Exp. 03/13; Lot # 11D002 Exp. 03/13; Lot#11K003 Exp. 09/13; Lot# 12C010 Exp. 02/14.

Product Distributed Qty 1772 bottles per 100 count each

Reason For Recall CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Event Detail

Event Id 64188

Product Type Drugs

Status Ongoing

Recalling Firm
TG United, Inc.
City Brooksville

State FL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-01-30

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern FL, MS, SC, LA and TX