Sodium Bicarbonate — Class II medical device recall Z-1811-2013
Terminated recall by Church & Dwight Inc, reported 2013-07-31, distributed nationwide. Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH So
| Recall number | Z-1811-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Church & Dwight Inc, Princeton, NJ, United States |
| Recall initiated | 2013-06-11 |
| Classified | 2013-07-25 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2015-06-30 |
| Distributed | Nationwide (US) |
| Lot numbers | FF3153, FF3154, FF3155, FF3156, FF3157, FF3158 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1811-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.