FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wm Bolthouse Farms Inc
- Product
- Bolthouse Farms Coffee Protein Plus: 30 g protein per bottl…
- Reason
- Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Atkins Nutritionals, Inc.
- Product
- Day Break Peanut Butter Fudge Crisp Bar 6x5, UPC: 6374800550…
- Reason
- Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Kellogg Company
- Product
- Kashi GOLEAN Honey Pecan Baklava Bars 1.59 oz. individual b…
- Reason
- Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Atkins Nutritionals, Inc.
- Product
- Cinnamon Bun Crisp Bar 6x5, UPC: 637480059251, Case UPC: 637…
- Reason
- Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Kellogg Company
- Product
- Kashi Whole Grain Bars 35 g individual bar, 18 count reta…
- Reason
- Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Atkins Nutritionals, Inc.
- Product
- Cashew Trail Mix Bar 6x5, UPC: 637480025850, Case UPC: 63748…
- Reason
- Atkins Nutritionals is recalling certain bar products because they contain or may have come in contact with equipment that processed product containing sunflower seeds distributed by supplier SunOpta Inc. that have the potential to be contaminated with Listeria monocytogenes.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Whole Foods Market Korean BBQ Sauce NET WT 12 OZ (340g) pack…
- Reason
- Undeclared peanut and coconut.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rucker's Wholesale & Service Co., Inc.
- Product
- HC SWEET N SALTY 3oz packaged in clear bags with attached br…
- Reason
- Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wm Bolthouse Farms Inc
- Product
- Bolthouse Farms Strawberry Protein Plus: 30 g protein per b…
- Reason
- Bolthouse Farms is recalling 8 varieties of Protein Plus and Perfectly Protein drinks due to spoilage that may cause beverage to appear lumpy and have an unpleasant taste and odor.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rucker's Wholesale & Service Co., Inc.
- Product
- Cajun Hot Mix 6 OZ. packaged in clear plastic bags with stic…
- Reason
- Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rucker's Wholesale & Service Co., Inc.
- Product
- HC SUNFLOWER KERNEL 3 OZ. packaged in a clear plastic bag wi…
- Reason
- Sunflower kernels in this product are contaminated with Listeria Monocytogenes per the original supplier, SunOpta.
- Published
- July 27, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
by West-Ward Columbus Inc
- Reason
- Failed Impurities/Degradation Specification; 9 month stability
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
by Apotex Scientific, Inc
- Reason
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
by Apotex Scientific, Inc
- Reason
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
by Apotex Scientific, Inc
- Reason
- Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
by Hospira Inc.
- Reason
- Crystallization: Product contains particulate identified to be crystallized active ingredient.
- Published
- July 20, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chinese characters.
by Murray International Trading Co., Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Published
- July 20, 2016
- 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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