The Recall Desk

Archive

January 2017 recalls

913 recalls were announced in January 2017.

What the numbers show

Critical
104
Severe
443
High
205
Moderate
130
Low
31

Of the 913 recalls this month scored against our rubric, 11% are Critical, 49% are Severe.

801–900 of 913

  • SevereFDA (Food)·F-0917-2017·2017-01-04

    Sunset Natural Products Recalls Fat Burner Dietary Supplement

    Sunset Natural Products Inc. is recalling Fat Burner dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Fat Burner, 45 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1079-2017·2017-01-04

    Sunset Natural Products Recalls De Pura Fibra Dietary Supplement

    Sunset Natural Products Inc. is recalling De Pura Fibra dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    De Pura Fibra Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1044-2017·2017-01-04

    Sunset Natural Products Recalls Aloe & L Glutamine Dietary Supplement

    Sunset Natural Products Inc. is recalling Aloe & L Glutamine Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Aloe & L Glutamine Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1020-2017·2017-01-04

    Sunset Natural Products Recalls Saw Palmetto Supplements Under Consent Decree

    Sunset Natural Products Inc. is recalling Saw Palmetto dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Saw Palmetto Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1027-2017·2017-01-04

    Sunset Natural Products Recalls Extra Mega Prostamax Dietary Supplement

    Sunset Natural Products Inc. is recalling Extra Mega Prostamax dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Extra Mega Prostamax Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1078-2017·2017-01-04

    Sunset Natural Products Recalls Gluco + Chond + MSM Dietary Supplement

    Sunset Natural Products Inc. is recalling Gluco + Chond + MSM dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Gluco + Chond + MSM, Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0994-2017·2017-01-04

    Sunset Natural Products Recalls DHEA 25 mg Bulk Capsules

    Sunset Natural Products Inc. is recalling DHEA 25 mg bulk capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    DHEA 25 mg, bulk capsules
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1011-2017·2017-01-04

    Sunset Natural Products Recalls Prostate Plus Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostate Plus dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Prostate Plus Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0913-2017·2017-01-04

    Sunset Natural Products Recalls Project #3 Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Project #3 dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Project #3, 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0916-2017·2017-01-04

    Sunset Natural Products Recalls Test Booster Dietary Supplement

    Sunset Natural Products Inc. is recalling Test Booster dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Test Booster, 90 or 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0920-2017·2017-01-04

    Sunset Natural Products Recalls Crea Care Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Crea Care capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Crea Care, (100,000 capsule bulk)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0933-2017·2017-01-04

    Sunset Natural Products Recalls Artrosamin Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling Artrosamin capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Artrosamin, 250,000 capsules per bulk order
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1008-2017·2017-01-04

    Sunset Natural Products Recalls Bio Moringa Dietary Supplement

    Sunset Natural Products Inc. is recalling Bio Moringa Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Bio Moringa Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1038-2017·2017-01-04

    Sunset Natural Products Recalls Muira Puama Dietary Supplement

    Sunset Natural Products Inc. is recalling Muira Puama dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Muira Puama, 50 mg, Dietary Supplement
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0959-2017·2017-01-04

    Sunset Natural Products Recalls Colageina Gold Dietary Supplement Jars

    Sunset Natural Products Inc. is recalling Colageina Gold dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Colageina Gold, 195 g Jars
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0995-2017·2017-01-04

    Sunset Natural Products Recalls Aloe Vera and Lecithin Capsules

    Sunset Natural Products Inc. is recalling Aloe Vera & Lecithin bulk capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Aloe Vera & Lecithin, bulk capsules
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0909-2017·2017-01-04

    GE Healthcare Recalls Legacy Systems Due to CRT Monitor Fall Risk

    GE Healthcare is recalling Legacy and other imaging systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.

    Product
    Legacy
    Category
    Medical Device
    Distribution
    41 states
  • HighCPSC·17064·2017-01-04

    Toshiba Laptop Battery Packs Recalled for Overheating and Fire Hazards

    Toshiba is expanding a recall of Panasonic lithium-ion battery packs for laptops due to overheating, burn, and fire risks. No injuries have been reported.

    Product
    Panasonic battery packs used in Toshiba laptop computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2017·2017-01-04

    Siemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk

    Siemens is recalling 13 SOMATOM Scope CT systems to replace a component that could cause a power cutout during use.

    Product
    SOMATOM Scope, Computed tomography x-ray system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0819-2017·2017-01-04

    Cargill Recalls Wilbur Semi-Sweet Chocolate Drops for Undeclared Milk

    Cargill Cocoa & Chocolate is recalling 50 lb. cartons of Wilbur Semi-Sweet Chocolate Drops because they may contain undeclared milk.

    Product
    Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Net Weight 50 lb.; This item may contain dairy products; Cargill Cocoa & Chocolate, Inc., Lititz, PA 17543; BATCH 28116AANCB and 28116AANCC Material number: 100000081 packed in cardboard boxes.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1039-2017·2017-01-04

    Sunset Natural Products Recalls Blanc Dietary Supplement Under Consent Decree

    Sunset Natural Products Inc. is recalling Blanc Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2, 2014.

    Product
    Blanc Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0906-2017·2017-01-04

    GE Healthcare Recalls CRT Monitors Due to Potential Fall Hazard

    GE Healthcare is recalling specific CRT monitors due to the potential for the units to fall. The recall affects multiple system models including ADVANTX and Prestige.

    Product
    ADVANTX LCLP+
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0918-2017·2017-01-04

    Shimadzu X-ray High Voltage Generator Recalled for Oil Leak Risk

    Shimadzu Medical Systems is recalling 13 X-ray high voltage generators due to a potential oil leak from the x-ray tube housing.

    Product
    Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-1085-2017·2017-01-04

    Mad Batter Bakery Cranberry Orange Scones Recalled for Undeclared Allergens

    Thomas Hammer Coffee Roasters is recalling Mad Batter Bakery Cranberry Orange Scones because they may contain undeclared milk, egg, soy, and wheat.

    Product
    Cranberry Orange Scone, brand Mad Batter Bakery, net wt. 5 oz per unit. Product is sold in a plastic film wrapper with labeling on the back of the package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1083-2017·2017-01-04

    Publix Pumpkin Pancake Mix Recalled Due to Salmonella Risk

    Publix is recalling Premium Pumpkin Pancake & Waffle Mix because the milk powder ingredient may contain Salmonella.

    Product
    Publix Premium Pumpkin Pancake & Waffle Mix, 16 oz box.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1082-2017·2017-01-04

    Publix Banana-Flavored Pancake Mix Recalled for Salmonella Risk

    Publix is recalling its Premium Banana-Flavored Chocolate Chip Pancake & Waffle Mix because the milk powder ingredient may contain Salmonella.

    Product
    Publix Premium Banana-Flavored Chocolate Chip Pancake & Waffle Mix, 16 oz box.
    Category
    Food
    Distribution
    6 states
  • HighCPSC·17063·2017-01-04

    Disney Recalls Infant Hoodies Due to Choking Hazard from Detaching Snaps

    Walt Disney Parks and Resorts is recalling Minnie and Mickey Mouse infant hoodie sweatshirts because the snaps can detach, posing a choking hazard to young children.

    Product
    Minnie and Mickey Mouse infant hoodie sweatshirts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2017·2017-01-04

    GE Healthcare Recalls X-Ray Systems Due to CRT Monitor Fall Risk

    GE Healthcare is recalling specific X-ray systems because aged CRT monitors may fall. The recall covers 1,598 units distributed in the US and internationally.

    Product
    SFX
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-0940-2017·2017-01-04

    Starlight Creatives Recalls Star-Shaped Blue Frosted Tea Cookies for Undeclared Soy

    Starlight Creatives, Inc. is recalling star-shaped, blue frosted tea cookies sold in Massachusetts because they contain undeclared soy lecithin.

    Product
    Star shaped, blue frosted tea cookies. The cookies were delivered in plain white pastry boxes and sold unpackaged at the supermarket on the supermarkets Tea Cookie Display.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0946-2017·2017-01-04

    Kerry Upgrade Bio WS Recalled Due to Bacillus cereus Contamination

    Kerry, Inc. is recalling 478 bags of Kerry Upgrade Bio WS because the product was identified as being adulterated with Bacillus cereus.

    Product
    Kerry Upgrade Bio WS, Net Wt. 50 lb (22068 kg), Item 5R01451.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0901-2017·2017-01-04

    Medtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes because wire in the tubing can become exposed, posing potential harm to intubated patients.

    Product
    NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2017·2017-01-04

    Siemens Recalls CT Systems for Potential Power Cutout Defect

    Siemens is recalling 13 SOMATOM Perspective CT systems to replace a component that could cause power cutouts during use.

    Product
    SOMATOM Perspective, Computed tomography x-ray system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0928-2017·2017-01-04

    Allen Medical Systems Recalls Arthex S3 Arm Sleeve Connectors

    Allen Medical Systems is recalling 420 Arthex S3 Arm Sleeve Connectors because they may separate unexpectedly during use, potentially causing moderate injury to patients.

    Product
    Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0876-2017·2017-01-04

    NeuViz 128 CT Scanner Software Recall for Scan Interruption Errors

    Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0956-2017·2017-01-04

    Sunset Natural Products Recalls Weight 2.0 Dietary Supplement

    Sunset Natural Products Inc. is recalling Weight 2.0 dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Weight 2.0, 120 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0917-2017·2017-01-04

    Shimadzu X-ray TV System Recalled for Oil Leak Risk

    Shimadzu Medical Systems is recalling 39 SONIALVISION G4 X-ray TV Systems due to a potential oil leak from the x-ray tube housing.

    Product
    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-0234-2017·2017-01-04

    Raritan Recalls CVS Kids' Ear Relief Liquid for Manufacturing Deviations

    Raritan Pharmaceuticals is voluntarily recalling 20,448 bottles of CVS pharmacy Kids' Ear Relief Oral Liquid due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0930-2017·2017-01-04

    Sterling Diagnostics Recalls HDL Cholesterol Kits Due to Expiration Date Error

    Sterling Diagnostics is recalling HDL Cholesterol diagnostic kits because previously extended expiration dates were rescinded.

    Product
    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0903-2017·2017-01-04

    Ortho-Clinical Diagnostics Recalls VITROS Intact PTH Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to a positive bias of up to 20% and an incorrectly set reference interval.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack, 2) UPN 10758750006250 / Product Code 6802893 - Calibrators For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1059-2017·2017-01-04

    Sunset Natural Products Recalls Libene Dietary Supplement Under Consent Decree

    Sunset Natural Products Inc. is recalling Libene Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

    Product
    Libene Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0934-2017·2017-01-04

    Sunset Natural Products Recalls Hepasil Dietary Supplement Capsules

    Sunset Natural Products Inc. is recalling 2,650,000 capsules of Hepasil pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Hepasil, (various bulk amounts)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0233-2017·2017-01-04

    Raritan Recalls Kids' Relief Ear Liquid Due to Manufacturing Deviations

    Raritan Pharmaceuticals is recalling 22,704 bottles of Kids' Relief Ear Relief Oral Liquid in New York due to CGMP deviations.

    Product
    Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0875-2017·2017-01-04

    Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error

    Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.

    Product
    NeuViz 64 Multi-slice CT Scanner Systems
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0937-2017·2017-01-04

    Sunset Natural Products Recalls Prostax Forte Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostax Forte dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Prostax Forte, (50,000 capsule bulk)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0236-2017·2017-01-04

    Sandoz Recalls Nadolol Tablets Due to Failed Dissolution Test

    Sandoz Incorporated is recalling 96 bottles of Nadolol Tablets, 40mg, because the product failed a required dissolution test.

    Product
    Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0902-2017·2017-01-04

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Disk Space Issue

    PerkinElmer Health Sciences is recalling 21 units of Specimen Gate Laboratory and eReports software because a defect may cause excessive disk space consumption, leading to software failure.

    Product
    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module o
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-1056-2017·2017-01-04

    Sunset Natural Products Recalls Denta Capsule Dietary Supplement

    Sunset Natural Products Inc. is recalling Denta capsule dietary supplements pursuant to a consent decree requiring the destruction of products manufactured or distributed since April 2014.

    Product
    Denta capsule Dietary Supplement (unknown container size)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0232-2017·2017-01-04

    CVS Health Homeopathic Infants Teething Tablets Recalled for CGMP Deviations

    Raritan Pharmaceuticals is voluntarily recalling CVS Health Homeopathic Infants Teething Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0961-2017·2017-01-04

    Sunset Natural Products Recalls Prostaliv New Dietary Supplement

    Sunset Natural Products Inc. is recalling Prostaliv New dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Prostaliv New, 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0240-2017·2017-01-04

    Virtus Pharmaceuticals Recalls Virt-Select Prenatal Softgels Due to GMP Deviations

    Virtus Pharmaceuticals is recalling Virt-Select Prenatal/Postnatal Softgels because the active ingredient manufacturer is on an FDA Import Alert for cGMP deviations.

    Product
    Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0906-2017·2017-01-04

    Bio-Botanica Recalls Vitamin D-3 Drops for Excess Dosage

    Bio-Botanica is recalling Nature's Answer and Seeking Health Vitamin D-3 drops because the lots contain more Vitamin D3 than the label claims.

    Product
    Liquid VITAMIN D-3 Drops distributed under the following private labels and sizes: a) NATURE'S ANSWER VITAMIN D-3 DROPS DIETARY SUPPLEMENT, 0.5 FLUID OZ/15 mL, UPC 8300026132 -- Nature's Answer Hauppauge, NY 11788; and b) Seeking Health Optimal Vitamin D, Liquid Vitamin D-3 Drops
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0932-2017·2017-01-04

    Sunset Natural Products Recalls Liver Energy Dietary Supplement

    Sunset Natural Products Inc. is recalling Liver Energy dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.

    Product
    Liver Energy, 100 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0958-2017·2017-01-04

    Sunset Natural Products Recalls Chardon De Marie Dietary Supplement

    Sunset Natural Products Inc. is recalling Chardon De Marie capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.

    Product
    Chardon De Marie, 60 capsules per bottle
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-0239-2017·2017-01-04

    Virtus Pharmaceuticals Recalls Extra-Virt Plus DHA Prenatal Softgels

    Virtus Pharmaceuticals is recalling 2,406 bottles of Extra-Virt Plus DHA Prenatal/Postnatal Softgels because the API manufacturer is on FDA Import Alert.

    Product
    Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0932-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Glucose Diagnostic Kits

    Sterling Diagnostics is recalling 40 units of Enzymatic Glucose diagnostic kits due to a revision of previously extended expiration dates.

    Product
    Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0237-2017·2017-01-04

    Cipher Pharmaceuticals Recalls Subpotent Inova Benzoyl Peroxide Pads

    Cipher Pharmaceuticals is recalling 216 boxes of Inova benzoyl peroxide pads due to subpotent drug levels. The product was distributed in Arizona, Colorado, and Ohio.

    Product
    INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only, packaged in a box containing: 30 pads of benzolyl peroxide 3g, 28 capsules of topical tocopherol 5%, OTC, Manufactured for: Innocutis Holdings, LLC, Charleston, SC 29401, NDC 68712-013-01
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-0238-2017·2017-01-04

    Virt-Advance Prenatal Softgels Recalled Due to API Manufacturer Import Alert

    Virtus Pharmaceuticals is recalling Virt-Advance Prenatal/Postnatal Softgels because the active ingredient manufacturer is on an FDA Import Alert.

    Product
    Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0929-2017·2017-01-04

    Sterling Diagnostics Recalls Enzymatic Cholesterol Diagnostic Kits

    Sterling Diagnostics is recalling 97 units of Enzymatic Cholesterol diagnostic kits due to a revision of previously extended expiration dates.

    Product
    Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0241-2017·2017-01-04

    VirtPrex Prenatal Tablets Recalled Due to API Manufacturer Import Alert

    Virtus Pharmaceuticals is recalling VirtPrex Prenatal/Postnatal Tablets because the active ingredient manufacturer is on an FDA Import Alert.

    Product
    VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
    Category
    Drug
    Distribution
    Distributed nationwide

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