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06-18-2013, 07:26 PM #1
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Recall: Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle
Product Description Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
Recall Number D-529-2013
Classification Class II
Code Info Lot# 12L005 Exp 10/14.
Product Distributed Qty 330158 Bulk tablets.
Reason For Recall CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Event Id 64188
Product Type Drugs
TG United, Inc.
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