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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65686

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Church & Dwight Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1811-2013
Initiated
June 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Church & Dwight Inc
Quantity
234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

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.

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.