Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1811-2013 · Posted 2013-07-25

Recalling FirmChurch & Dwight Inc
Recall StatusTerminated
Date Initiated2013-06-11
Date Terminated2015-06-30
Product Quantity234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2

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.

Firm Action

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.

Root Cause

Material/Component Contamination

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑