Product Detail

Product Description AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant,
Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

Recall Number D-509-2013

Classification Class II

Code Info Lot # 12DQ004, Exp. 03/14.

Product Distributed Qty 355 - 16 ounce bottles

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