CLASS II Device recall · Reported 31 Jul 2013 · FDA Enforcement Report

Sodium Bicarbonate, USP Provided bulk as raw material recalled

Church & Dwight is recalling Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to, distributed nationwide in the US. The recall was initiated on 11 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 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

Quantity recalled234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1811-2013
FDA event ID: 65686
Recalling firm: Church & Dwight, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 11 Jun 2013
FDA classified: 25 Jul 2013
Reported: 31 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

11 Jun 2013	Recall initiated by company
25 Jul 2013	Classified by FDA	+44 days
31 Jul 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Illinois Indiana Kentucky Maryland Michigan Minnesota Missouri New Jersey Ohio Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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