The Recall Desk

Archive

February 2018 recalls

833 recalls were announced in February 2018.

What the numbers show

Critical
22
Severe
228
High
281
Moderate
281
Low
21

Of the 833 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.

501–600 of 833

  • HighFDA (Food)·F-0777-2018·2018-02-14

    Stevens Bakery Recalls Blackberry Pies for Undeclared Milk Allergen

    Stevens Family Bakery & Orchard LLC is recalling 25 blackberry pies because the label failed to declare milk, a major allergen, in the ingredient statement.

    Product
    Blackberry Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0707-2018·2018-02-14

    Wienke's Market Black Raspberry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Black Raspberry Jam because it contains butter, which is not declared on the label.

    Product
    Wienke's Market Black Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00203. Refrigerate after opening. Ingredients: black raspberries, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0720-2018·2018-02-14

    Wienke's Market Cranberry Jam Recalled for Undeclared Butter Allergen

    Wienke LLC is recalling Wienke's Market Cranberry Jam because it contains butter, an ingredient not declared on the label.

    Product
    Wienke's Market Cranberry Jam, Net Wt. 8 oz (226g), UPC 14106-00217. Refrigerate after opening. Ingredients: cranberries, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0708-2018·2018-02-14

    Wienke's Black Raspberry Jam Recalled for Undeclared Butter Allergen

    Wienke LLC is recalling Wienke's Market Seedless Black Raspberry Jam because it contains butter, which is not declared on the label.

    Product
    Wienke's Market Seedless Black Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00204. Refrigerate after opening. Ingredients: black raspberry puree, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0712-2018·2018-02-14

    Wienke's Market Boysenberry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Boysenberry Jam because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market Boysenberry Jam, Net Wt. 8 oz (226g), UPC 14106-00208. Refrigerate after opening. Ingredients: boysenberries, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0749-2018·2018-02-14

    Wienke's Market Strawberry Rhubarb Jam Recalled for Undeclared Butter

    Wienke LLC is recalling No Sugar Added Strawberry Rhubarb Jam because it contains butter that is not listed on the label.

    Product
    Wienke's Market No Sugar Added Strawberry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00319. Refrigerate after opening. Ingredients: strawberries, rhubarb, rice syrup, grape juice, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0731-2018·2018-02-14

    Wienke's Market Rhubarb Jam Recalled for Undeclared Butter Allergen

    Wienke LLC is recalling Wienke's Market Rhubarb Jam because it contains butter, an ingredient not declared on the label.

    Product
    Wienke's Market Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00230. Refrigerate after opening. Ingredients: rhubarb, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0740-2018·2018-02-14

    Wienke's Blackberry Jam Recalled for Undeclared Butter Allergen

    Wienke LLC is recalling Wienke's Market No Sugar Added Blackberry Jam because it contains butter, which is not declared on the label.

    Product
    Wienke's Market No Sugar Added Blackberry Jam, Net Wt. 8 oz (226g), UPC 14106-00302. Refrigerate after opening. Ingredients: blackberries, rice syrup, grape juice, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0714-2018·2018-02-14

    Wienke's Market Hot Cherry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Hot Cherry Jam because it contains butter, an ingredient not declared on the label.

    Product
    Wienke's Market Hot Cherry Jam, Net Wt. 8 oz (226g), UPC 14106-00211. Refrigerate after opening. Ingredients: cherries, sweet red peppers, onion, hot peppers, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0733-2018·2018-02-14

    Wienke's Strawberry Jam Recalled for Undeclared Butter Allergen

    Wienke LLC is recalling Wienke's Market Seedless Strawberry Jam because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market Seedless Strawberry Jam, Net Wt. 8 oz (226g), UPC 14106-00232. Refrigerate after opening. Ingredients: strawberry puree, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0778-2018·2018-02-14

    Stevens Bakery Cherry Pies Recalled for Undeclared Milk Allergen

    Stevens Family Bakery & Orchard LLC is recalling cherry pies because the label failed to list butter, which contains milk, as an ingredient.

    Product
    Cherry Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0799-2018·2018-02-14

    Recall of Don Bocarte Migs Bonito Del Norte Due to Histamine Levels

    Despana Brand Foods is recalling 120 jars of Don Bocarte Migs Bonito Del Norte because the product may contain elevated levels of histamine.

    Product
    DON BOCARTE ARTE EN EL PALADAR MIGAS BONITO DEL NORTE PESCA SELECTA DEL CANTABRICO; UPC: 8 43700227144
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0757-2018·2018-02-14

    Mountain Rose Recalls Prickly Ash Bark Powder Due to Salmonella Risk

    Mountain Rose Inc is recalling Prickly Ash Bark Powder herbal supplements due to potential Salmonella contamination. The product was distributed in 30 states.

    Product
    Prickly Ash Bark Powder Herbal Supplement, packaged in food grade stand up plastic pouches or plastic bags depending on quantity ordered, various net weights - 1-oz., 4-oz., 8-oz., 1-lb., 2-lb., 5-lb., 7-lb., 11-lb., 15-lb., and 16-lb. The label is read in parts: "***Prickly A
    Category
    Food
    Distribution
    29 states
  • HighFDA (Food)·F-0794-2018·2018-02-14

    SunGlow Butter Blend Margarine Recalled for Undeclared Soy Lecithin

    Ventura Foods is recalling SunGlow Unsalted European Style Butter Blend Margarine because it contains undeclared soy lecithin, a common allergen.

    Product
    SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g. Keep Refrigerated. UPC 26700-13499. Outer case: Net Wt 36 lb (16.32 kg). UPC 1 00 26700 13499 6. Ventura Foods, Brea, CA 92821
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0517-2018·2018-02-14

    Panoramic PC-1000 Dental X-ray Units Recalled for Lift Motor Wear

    Panoramic Rental Corp. is recalling PC-1000 dental X-ray units because the lift motor may wear if not properly maintained, posing a risk of injury.

    Product
    PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.

    Product
    Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2018·2018-02-14

    Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators Due to Malfunction

    Angiodynamics, Inc. is recalling 14,353 Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.

    Product
    Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0594-2018·2018-02-14

    Hetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations

    Hetero Labs is recalling 3,000 bottles of Aripiprazole 10 mg tablets because the active ingredient did not meet all intended specifications.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0552-2018·2018-02-14

    3M Recalls ACE Ultra Lite Ankle Braces Due to Mold Contamination

    3M is recalling specific sizes of ACE Ultra Lite Ankle Braces because mold was found on non-patient contact surfaces. The mold was identified as Aspergillus candidus.

    Product
    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-0518-2018·2018-02-14

    Philips Brilliance 64 CT System Recalled for Software Issues

    Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.

    Product
    Philips Brilliance 64 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0522-2018·2018-02-14

    Philips Ingenuity TF PET/CT Recalled for Missing Gantry Mounting Hardware

    Philips is recalling two Ingenuity TF PET/CT systems because one wire channel inside the Gantry Separation Unit was missing mounting hardware.

    Product
    Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0548-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification Gap

    Zimmer Biomet is recalling 1,517 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm lengths.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in gu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0540-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems 25 mcg/h because a degradation product exceeded specification limits.

    Product
    Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0537-2018·2018-02-14

    Medtronic Ascenda Intrathecal Catheter Recall for Kinking Risk

    Medtronic is recalling specific lots of Ascenda Intrathecal Catheters due to a potential risk of kinking at the proximal end where the catheter connects to the drug infusion pump.

    Product
    Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Levels

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because they contain a degradant called Fentanyl-n-Oxide that exceeds safety limits.

    Product
    Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0524-2018·2018-02-14

    Siemens Syngo.plaza PACS Software Recall for Workflow Display Error

    Siemens is recalling 76 Syngo.plaza systems with SW VB20A because prior studies may not replace correctly in all workflow steps, potentially showing outdated images.

    Product
    Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0521-2018·2018-02-14

    Philips Ingenuity CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity CT systems due to software issues in version 4.1.6. The recall affects 26 US government accounts.

    Product
    Philips Ingenuity CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0723-2018·2018-02-14

    Wienke's Market Gooseberry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Gooseberry Jam because it contains butter that is not listed on the label.

    Product
    Wienke's Market Gooseberry Jam, Net Wt. 8 oz (226g), UPC 14106-00220. Refrigerate after opening. Ingredients: gooseberries, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0548-2018·2018-02-14

    Astellas Recalls Mycamine Injection Vials Due to Labeling Error

    Astellas Pharma US Inc is recalling 63,600 vials of Mycamine (micafungin sodium) for Injection due to a label error on the declared strength.

    Product
    MYCAMINE — MYCAMINE (MICAFUNGIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0728-2018·2018-02-14

    Wienke's Market Hot Raspberry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Hot Raspberry Jam because it contains butter that is not listed on the label.

    Product
    Wienke's Market Hot Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00240. Refrigerate after opening. Ingredients: raspberries, sweet red peppers, onion, hot peppers, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0721-2018·2018-02-14

    Wienke's Market Currant Jelly Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Currant Jelly because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market Currant Jelly, Net Wt. 8 oz (226g), UPC 14106-00219. Refrigerate after opening. Ingredients: currant juice, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0525-2018·2018-02-14

    ConvaTec Recalls Mislabelled Ostomy Skin Barrier Products

    ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.

    Product
    SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0543-2018·2018-02-14

    Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter

    Robert Busse & Co. is recalling 5 cases of Safety Deluxe Bone Marrow Biopsy/Aspiration Trays due to the presence of loose polypropylene foreign matter.

    Product
    Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2018·2018-02-14

    Flawless Beauty Recalls Laroscorbine Platinum Vitamin C Due to Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Laroscorbine Platinum Vitamin C products because they were marketed without an approved NDA or ANDA.

    Product
    Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification

    Zimmer Biomet is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guidin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0711-2018·2018-02-14

    Wienke's Blueberry Rhubarb Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Blueberry Rhubarb Jam because it contains butter that is not listed on the label.

    Product
    Wienke's Market Blueberry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00207. Refrigerate after opening. Ingredients: blueberries, rhubarb, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0425-2018·2018-02-14

    Millennium Pharmaceuticals Recalls VELCADE Injection Vials Due to Defective Crimps

    Millennium Pharmaceuticals is recalling 154,372 vials of VELCADE (bortezomib) for injection due to confirmed reports of loose vial crimps.

    Product
    VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distribu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0546-2018·2018-02-14

    Busse Bone Marrow Biopsy Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety Deluxe Bone Marrow Biopsy/Aspiration Trays because they may contain loose polypropylene foreign matter.

    Product
    Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2018·2018-02-14

    Busse Laceration Tray Recall Due to Foreign Matter

    Busse Hospital Disposables is recalling Laceration Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0526-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0553-2018·2018-02-14

    Binding Site Rheumatoid Factor Kit Recalled for Control Value Deviations

    The Binding Site Group is recalling Rheumatoid Factor kits because low and high controls are returning results above assigned values.

    Product
    Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This t
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0724-2018·2018-02-14

    Wienke's Market Hot Pepper Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market Hot Pepper Jam because it contains butter, an ingredient not declared on the label.

    Product
    Wienke's Market Hot Pepper Jam, Net Wt. 8 oz (226g), UPC 14106-00221. Refrigerate after opening. Ingredients: sweet red peppers, onion, hot peppers, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0773-2018·2018-02-14

    Titan Potato Puffs Recalled for Undeclared Sodium Bisulfite Ingredient

    Empresas Barsan, Inc. is recalling Titan potato puffs in Puerto Rico because the label fails to declare sodium bisulfite as an ingredient.

    Product
    TITAN, 24 rellenos de papas, (potato puffs), Net WT 6.75 LB (pounds)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0809-2018·2018-02-14

    Bobo's Coconut Oat Bars Recalled Due to Mold Contamination

    Simply Delicious, Inc. is recalling Bobo's Coconut Oat Bars because they may contain mold. The recall covers 588 master cases distributed nationwide.

    Product
    Bobo's Coconut Oat Bar 3oz. Packaged in overwrap film per single bar
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2018·2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 1,631 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.25 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0540-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety-Deluxe Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0519-2018·2018-02-14

    Philips Ingenuity Core CT System Software Recall

    Philips Medical Systems is recalling Ingenuity Core CT systems due to software issues in Brilliance iCT 4.1.6.

    Product
    Philips Ingenuity Core computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0549-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wire Ball Tip Due to Packaging Design Verification

    Zimmer Biomet is recalling 7,888 Humeral Guide Wire Ball Tip units because the previous packaging configuration lacks design verification for 70cm wires.

    Product
    Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0520-2018·2018-02-14

    Philips CT System Recalled for Software Issues

    Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.

    Product
    Philips Ingenuity Core 128 computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0529-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0739-2018·2018-02-14

    Wienke's Apple Butter Recalled for Undeclared Butter Ingredient

    Wienke LLC is recalling No Sugar Added Apple Butter because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market No Sugar Added Apple Butter, Net Wt. 8 oz (226g), UPC 14106-00300. Refrigerate after opening. Ingredients: apples, cinnamon, cloves, allspice.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0338-2018·2018-02-14

    McKesson Recalls Subpotent Megestrol Acetate Oral Suspension

    McKesson Packaging Services is recalling Megestrol Acetate Oral Suspension because stability testing found the drug was subpotent.

    Product
    Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0735-2018·2018-02-14

    Wienke's Market Strawberry Cherry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Strawberry Cherry Jam because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market Strawberry Cherry Jam, Net Wt. 8 oz (226g), UPC 14106-00234. Refrigerate after opening. Ingredients: strawberries, cherries, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-0747-2018·2018-02-14

    Wienke's Market Strawberry Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Wienke's Market No Sugar Added Strawberry Jam because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market No Sugar Added Strawberry Jam, Net Wt. 8 oz (226g), UPC 14106-00315. Refrigerate after opening. Ingredients: strawberries, rice syrup, grape juice, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0533-2018·2018-02-14

    MedComp Recalls CT Port Kits Packaged With Incorrect Needle Size

    Medical Components, Inc. is recalling 65 units of CT Port kits that were packaged with 21G needles instead of the labeled 18G needles.

    Product
    6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medi
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0541-2018·2018-02-14

    Busse Safety-Deluxe Biopsy Tray Recalled for Foreign Matter

    Robert Busse & Co. is recalling Safety-Deluxe Basic Soft Tissue Biopsy Trays because they may contain loose polypropylene foreign matter.

    Product
    Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.50 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0555-2018·2018-02-14

    Cyberonics Recalls Two VNS Therapy Programmer Units Distributed Before Approval

    Cyberonics, Inc. is recalling two VNS Therapy Programmer units that were distributed in error before FDA approval of the specific software version.

    Product
    VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and olde
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0542-2018·2018-02-14

    Busse Lumbar Puncture Tray Recalled for Foreign Matter

    Busse Hospital Disposables is recalling Safety-Deluxe Lumbar Puncture Trays because they may contain loose polypropylene foreign matter above release specifications.

    Product
    Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0793-2018·2018-02-14

    Rico Tofu Breakfast Burrito Recalled for Undeclared Soy

    Rico Brand is recalling 164 frozen Tofu Breakfast Burritos because they contain undeclared soy. The product was distributed to 20 retail stores in Utah.

    Product
    Rico Tofu Breakfast Burrito, 12 oz, wrapped in white paper. Frozen.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0538-2018·2018-02-14

    Exactech Recalls Alteon HA Femoral Stems Due to Labeling Error

    Exactech is recalling 34 Alteon HA Femoral Stems because the labels incorrectly described the device. The units were distributed to five US states.

    Product
    Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecros
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0814-2018·2018-02-14

    Olde Thompson BBQ Grinder Recalled for Incorrect Sodium Labeling

    Olde Thompson is recalling Sweet & Smoky BBQ Grinders because the label states 0 mg sodium, but the product contains 350 mg per serving.

    Product
    Olde Thompson Sweet & Smoky BBQ Grinder NET WT. 6.7 oz. (189.9g) Olde Thompson Oxnard, CA Ingredients: Sea Salt, demerara sugar, Dehydrated garlic, chili pepper, mustard seed, paprika, black pepper, oregano, coriander seed, cumin seed, natural hickory smoke flavor, thyme
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0772-2018·2018-02-14

    Titan Potato Puffs Recalled for Undeclared Sodium Bisulfite Ingredient

    Empresas Barsan, Inc. is recalling Titan Potato Puffs with Meat Flavor because the label fails to declare Sodium Bisulfite as an ingredient.

    Product
    TITAN, 6 rellenos, Potato Puffs with Meat Flavor, Net Weight 26.4 oz (748g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0325-2018·2018-02-14

    Flawless Beauty Recalls Relumins Vitamin C Ampules for Misbranding

    Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules because they were marketed without an approved NDA or ANDA.

    Product
    Relumins Vitamin C Solvent ampules
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0781-2018·2018-02-14

    Stevens Bakery Recalls No Sugar Added Pumpkin Pies for Missing Aspartame Warning

    Stevens Family Bakery & Orchard LLC is recalling No Sugar Added Pumpkin Pies because the labels failed to include the required warning statement for aspartame.

    Product
    No Sugar Added Pumpkin Pie Baked whole pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0550-2018·2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 10,116 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0719-2018·2018-02-14

    Wienke's Market Cherry Rhubarb Jam Recalled for Undeclared Butter

    Wienke LLC is recalling Cherry Rhubarb Jam because it contains butter, an ingredient not listed on the label.

    Product
    Wienke's Market Cherry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00216. Refrigerate after opening. Ingredients: cherries, rhubarb, sugar, pectin.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0515-2018·2018-02-14

    Siemens ADVIA Centaur Calibrator 30 Recalled for Negative Bias

    Siemens is recalling ADVIA Centaur Calibrator 30 kits because they cause negative bias in Estradiol tests on specific systems.

    Product
    ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0250-2018·2018-02-14

    G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Discoloration

    G & W Laboratories is recalling 142,236 tubes of Ciclopirox Olamine Cream USP, 0.77%, due to yellow discoloration. The product is distributed nationwide and in Puerto Rico.

    Product
    CICLOPIROX OLAMINE — CICLOPIROX OLAMINE (CICLOPIROX OLAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0543-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0541-2018·2018-02-14

    Teva Recalls Fentanyl Patches Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·18097·2018-02-13

    Tea Collection Recalls Children's Rompers Due to Choking Hazard

    Tea Collection is recalling about 3,800 children's rompers because snaps near the collar can detach, posing a choking hazard to young children.

    Product
    Children's rompers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowNHTSA·18V105000·2018-02-13

    Gulf Stream Recalls 2018 Matrix and Geo Trailers for Label Errors

    Gulf Stream is recalling 2018 Matrix and Geo recreational trailers because the Federal Certification Labels incorrectly list the rear axle weight rating.

    Product
    GULF STREAM — GULF STREAM MATRIX, GEO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V104000·2018-02-12

    Ford Recalls 2018 Escape and Lincoln MKC for Brake Hose Defect

    Ford is recalling 2018 Escape and Lincoln MKC vehicles because incorrect front brake hoses may chafe and leak fluid, increasing stopping distance.

    Product
    LINCOLN — LINCOLN, FORD MKC, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V102000·2018-02-09

    Volkswagen Recalls 2017-2018 Tiguan Limited for Incorrect Front Driver Air Bag

    Volkswagen is recalling 2017-2018 Tiguan Limited vehicles because the front driver air bag may not be intended for US use, failing federal safety standards and increasing injury risk in a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V103000·2018-02-09

    Mitsubishi Recalls Outlander Sport for Wiper Link Corrosion Risk

    Mitsubishi is recalling 2011-2016 Outlander Sport vehicles because water intrusion may corrode the wiper link, causing wipers to stop working and reducing visibility.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V101000·2018-02-08

    Micro Bird Recalls T-Series Transit Buses Due to Seat Belt Anchor Defect

    Micro Bird is recalling 2015-2018 T-Series transit buses because seat belt attachments may not remain secured to the floor in a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18096·2018-02-08

    Fujitsu Recalls Notebook Computer Battery Packs Due to Fire and Burn Hazards

    Fujitsu is recalling specific lithium-ion battery packs for notebook computers and workstations because they can overheat, posing fire and burn risks.

    Product
    Battery packs used in Fujitsu notebook computers and workstations.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18095·2018-02-08

    Husqvarna Recalls Zero Turn Riding Mowers Due to Fire Hazard

    Husqvarna is recalling about 7,100 residential zero turn riding mowers because a fuel line defect can cause leaks and fire. No injuries have been reported.

    Product
    Residential zero turn riding mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18723·2018-02-08

    Poppin Recalls Pitch Rolling Chairs Due to Fall Hazard

    Poppin is recalling about 2,800 Pitch rolling chairs because the seat plate can break and detach, posing a fall hazard. No injuries have been reported.

    Product
    Pitch rolling chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V100000·2018-02-08

    RAM Trucks Recalled for Transmission Shift Interlock Defect

    Chrysler is recalling 2017-2018 RAM trucks because the brake pedal interlock may fail, allowing the vehicle to shift out of Park without the brake pedal being pressed.

    Product
    RAM — RAM 2500, 5500, 1500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V098000·2018-02-08

    Chrysler Recalls 2017 Jeep Wrangler and Dodge Caravan for Brake Switch Defect

    Chrysler is recalling 2017 Jeep Wrangler and Dodge Caravan vehicles because brake switches may malfunction, allowing the vehicle to shift out of Park without the brake pedal being pressed.

    Product
    JEEP — JEEP, DODGE WRANGLER, CARAVAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0558-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.

    Product
    LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0247-2018·2018-02-07

    Blue Pearl Capsules Recalled for Undeclared Sildenafil

    Blue Fusion Natural is recalling Blue Pearl capsules because FDA analysis found undeclared sildenafil, an unapproved drug for erectile dysfunction.

    Product
    BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0563-2018·2018-02-07

    FDA Recalls Unapproved Zhonghua Niubian Tablets Containing Sildenafil

    A&H Focal Inc. is recalling Zhonghua Niubian tablets found to contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0472-2018·2018-02-07

    Clopidogrel Tablets Recalled Due to Simvastatin Labeling Error

    International Laboratories, LLC is recalling Clopidogrel Tablets 75 mg because bottles were found containing Simvastatin Tablets 10 mg.

    Product
    Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2018·2018-02-07

    Medline Laceration Tray Recalled for Subpotent Povidone-Iodine Concentration

    Medline Industries is recalling 600 cases of Laceration Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0554-2018·2018-02-07

    FDA Recalls Unapproved Miraculous Evil Root Capsules Containing Sildenafil

    A&H Focal Inc. is recalling Miraculous Evil Root capsules because FDA analysis found they contain sildenafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0290-2018·2018-02-07

    Medline Skin Staple Remover Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling Skin Staple Remover Kits because the iodine content is below the label claim of 0.85%.

    Product
    Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2018·2018-02-07

    FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets

    A&H Focal Inc. is recalling DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.

    Product
    DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0567-2018·2018-02-07

    Unapproved Yanshijiaonang Capsules Containing Sildenafil Recalled by FDA

    A&H Focal Inc. is recalling Yanshijiaonang capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.

    Product
    YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0273-2018·2018-02-07

    Medline Dressing Change Tray Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling Dressing Change Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide

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