FDA Drug Recalls

Recalls / Class II

Class IID-797-2013

Product

Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60111.

Affected lot / code info
Lot #: FF3153, FF3154, FF3155, FF3156, FF3157, and FF3158

Why it was recalled

Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.

Recalling firm

Firm
Church & Dwight Inc
Notification channel
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type
Voluntary: Firm initiated
Address
469 N Harrison St, N/A, Princeton, New Jersey 08540-3510

Distribution

Quantity
749 tons total
Distribution pattern
Nationwide

Timeline

Recall initiated
2013-06-11
FDA classified
2013-07-12
Posted by FDA
2013-07-24
Terminated
2015-06-30
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-797-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls