Recall Z-1811-2013— Church & Dwight Inc
Class II · Terminated
Class II FDA medical device recall by Church & Dwight Inc, initiated 2013-06-11, terminated 2015-06-30. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Church & Dwight Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-11
- Terminated
- 2015-06-30
- Firm location
- Princeton, NJ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.