Church & Dwight Inc
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
| Date | Jul 25, 2013 (initiated Jun 11, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| 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. |
| Quantity | 234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2 |
| Distribution | Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.