Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 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. 5 Coarse Granular, 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 #60511. Class II

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

Church & Dwight Inc 20130611 Terminated
Distributed: Nationwide
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, 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 #60411. Class II

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

Church & Dwight Inc 20130611 Terminated
Distributed: Nationwide
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 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. 3 Fine 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 #60311. Class II

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

Church & Dwight Inc 20130611 Terminated
Distributed: Nationwide
Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 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. 2 Fine Granular, 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 #60211. Class II

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

Church & Dwight Inc 20130611 Terminated
Distributed: Nationwide
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. Class II

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

Church & Dwight Inc 20130611 Terminated
Distributed: Nationwide
Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Class II

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy 20130529 Ongoing
Distributed: Nationwide and PR
Xylazine 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Class II

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy 20130529 Ongoing
Distributed: Nationwide and PR
Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL Class II

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy 20130529 Ongoing
Distributed: Nationwide and PR
Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL Class II

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy 20130529 Ongoing
Distributed: Nationwide and PR
Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL Class II

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Lowlite Investments, Inc. D/B/A Olympia Pharmacy 20130529 Ongoing
Distributed: Nationwide and PR
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Data provided by openFDA