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U.S. Department of Health and Human Services

Class 2 Device Recall Church and Dwight Inc. Sodium Bicarbonate, USP

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 Class 2 Device Recall Church and Dwight Inc. Sodium Bicarbonate, USP see related information
Date Posted July 25, 2013
Recall Status1 Terminated on June 30, 2015
Recall Number Z-1811-2013
Recall Event ID 65686
Product 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
Code Information Lots
FF3153, FF3154, FF3155, FF3156, FF3157, AND FF3158

Product Name
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
Recalling Firm/
Manufacturer
Church & Dwight Inc
469 N Harrison St
Princeton NJ 08540-3510
For Additional Information Contact Mr. Jeffrey Shaul
609-806-1992
Manufacturer 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.
FDA Determined
Cause 2
Material/Component Contamination
Action Church and Dwight Inc., issued an Urgent Recall letter dated June 11, 2013, and return response form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine and return the affected product. For questions regarding this recall call 609-279-7748.
Quantity in Commerce 234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2
Distribution Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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