FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ikea North America Srvcs Inc
- Product
- Choklad Lingon & Blabar Assortment of milk chocolate Squares…
- Reason
- IKEA N.A. Services, LLC Voluntarily Issues Expanded Recall and Allergy Alert on Undeclared Milk, Almond, and/or Hazelnut on Certain IKEA Chocolate Products. CHOKLAD MORK, CHOKLAD MORK 70%, CHOKLAD LINGON & BLABAR, CHOKLAD NOT, GODIS CHOKLADKROKANT, GODIS CHOKLADRAN and CHOKLAD LJUS, are being recalled due to undeclared Milk, Hazelnuts and/or Almond. All Best Before Dates, Sold from April 30, 2015 to July 1, 2016. CHOKLAD LINGON & BLABAR, 6.3 0z (180g), UPC: 1602184210009. Due to manufacturing process, the product contains the undeclared ingredients Hazelnut and Almond. The labeling carries a "May Contain" statement identifying Almonds and Hazelnuts.
- Published
- April 12, 2017
- Distribution
- AZ CA Co CT FL GA IL KS MA MD…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ikea North America Srvcs Inc
- Product
- Dark Chocolate bars Choklad Mork Dark Chocolate, Net Wt. 3.…
- Reason
- IKEA N.A. Services, LLC Voluntarily Issues Expanded Recall and Allergy Alert on Undeclared Milk, Almond, and/or Hazelnut on Certain IKEA Chocolate Products. CHOKLAD MORK, CHOKLAD MORK 70%, CHOKLAD LINGON & BLABAR, CHOKLAD NOT, GODIS CHOKLADKROKANT, GODIS CHOKLADRAN and CHOKLAD LJUS, are being recalled due to undeclared Milk, Hazelnuts and/or Almond. All Best Before Dates, Sold from April 30, 2015 to July 1, 2016. CHOKLAD MORK Dark Chocolate Bar, 3.5 oz. (100g), UPC: 1002939270003. Product has a may contain qualifying statement for milk, Almond and Hazelnut. The manufacturer's process adds Milk, Almond, Hazelnut to the chocolate but the label fails to declare milk, almond and hazelnut as ingredients. CHOKLAD MORK 70% Dark Chocolate Bars, 3.5 0z. (100g), UPC: 1203080940009, Contains: Milk, Almond, Hazelnut as ingredients. However, these allergens are declared in a "may contain statement" identifying the allergens as Milk and Treenuts.
- Published
- April 12, 2017
- Distribution
- AZ CA Co CT FL GA IL KS MA MD…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, Walton Umbe…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, Hamden, NET…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, Blue Blais
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, ANDES, NET…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, Willowemoc,…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, heinennelli…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, Miranda, NE…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vulto Creamery
- Product
- artisanal cheese VULTO Creamery HANDMADE CHEESE, Ouleout, NE…
- Reason
- Listeria monocytogenes contamination
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
by Hetero USA Inc
- Reason
- Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
by Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
by Claris Lifesciences Inc
- Reason
- Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
by GSK Consumer Healthcare
- Reason
- Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
by Mylan Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
- Published
- April 5, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications; 9 month long term stability
- Published
- April 5, 2017
- 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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