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06-18-2013, 07:45 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
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Recall: Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count
Product Description Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
Recall Number D-531-2013
Classification Class II
Code Info Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.
Product Distributed Qty 978,092 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