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
- Company
- Church & Dwight Inc
- Recall Initiated
- June 11, 2013
- Posted
- July 25, 2013
- Terminated
- June 30, 2015
- Recall Number
- Z-1811-2013
- Quantity
- 234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2
- Firm Location
- Princeton, NJ
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.
Distribution
Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.
Lot / Code Info
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
Root Cause
Material/Component Contamination
Action Taken
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.