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Recall Observatory FDA recall evidence

Device 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

Z-1811-2013

June 11, 2013

Class II

Product summary

Firm
Church & Dwight Inc
Event
Event 65686
Status
Terminated
Classification
Class II
Quantity
234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2
Official record key
device-enforcement:Z-1811-2013

Official wording

Reason: 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.

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

Distribution pattern: Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.