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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
Recall Number Z-1811-2013
Classification Class II
Code Info Lots and sizes- 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015443 SBC DIALYSIS 2 GRADE 50 LB BAG
Product Distributed Qty 234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2
Reason For Recall Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.

Event Detail

Event Id 65686
Product Type Devices
Status Ongoing
Recalling Firm Church & Dwight Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-11
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.
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