FDA Recall
TerminatedTerminated: August 21, 2013Historical recordClass II
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
by American Health Packaging
- Reason
- Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
- Published
- July 24, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 30, 2015Historical recordClass II
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.
by Church & Dwight Inc
- Reason
- Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
- Published
- July 24, 2013
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 30, 2015Historical recordClass II
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.
by Church & Dwight Inc
- Reason
- Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
- Published
- July 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 30, 2015Historical recordClass II
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.
by Church & Dwight Inc
- Reason
- Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
- Published
- July 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 30, 2015Historical recordClass II
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.
by Church & Dwight Inc
- Reason
- Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
- Published
- July 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 30, 2015Historical recordClass II
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.
by Church & Dwight Inc
- Reason
- Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination.
- Published
- July 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Methylcobalamin 1 mg/ml / Folic Acid 2.5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
by Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Reason
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Published
- July 17, 2013
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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