Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialys

FDA device recall Z-1811-2013 · posted 2013-07-25 · Terminated

Recall details

Recalling firm

Church & Dwight Inc

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.

Action taken

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

Status

Terminated

Quantity affected

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.

Date initiated

2013-06-11

Date posted

2013-07-25

Date terminated

2015-06-30

Location

Princeton, NJ