The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
216
High
442
Moderate
156
Low
24

Of the 896 recalls this month scored against our rubric, 6% are Critical, 24% are Severe.

601–700 of 896

  • HighFDA (Drugs)·D-0911-2016·2016-06-08

    Baptist Health Recalls Sodium Chloride IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 0.9% Sodium Chloride IV bags in Arkansas due to a lack of sterility assurance.

    Product
    0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0935-2016·2016-06-08

    Baptist Health Recalls 53 Bags of Piperacillin-Tazobactam Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling 53 bags of IV piperacillin-tazobactam in Arkansas due to a lack of sterility assurance.

    Product
    Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0930-2016·2016-06-08

    Baptist Health Recalls Milrinone IV Bags Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling Milrinone IV bags in Arkansas due to a lack of sterility assurance.

    Product
    Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1868-2016·2016-06-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterile Barrier Concerns

    Windstone Medical Packaging is recalling specific Laparotomy Packs because the included Medtronic Kerlix sponges may have compromised sterile barriers.

    Product
    Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2016·2016-06-08

    Ventlab STAT-Check Resuscitation Bag Recall Due to Non-Functional CO2 Indicators

    Ventlab LLC is recalling STAT-Check Resuscitation Bags because the carbon dioxide indicators are non-functional and fail to change color during use.

    Product
    STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should onl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2016·2016-06-08

    Greatbatch Medical Recalls Torque Limiting Devices Due to Sterility Failure

    Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.

    Product
    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1846-2016·2016-06-08

    Sterilmed Recalls Reprocessed Microline Scissor Tips Due to Manufacturing Defect

    Sterilmed is recalling 11,326 reprocessed Microline Scissor Tips due to a potential manufacturing defect that could result in patient injury.

    Product
    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, M
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Drugs)·D-0923-2016·2016-06-08

    Baptist Health Recalls Deferoxamine Cassettes Due to Sterility Concerns

    Baptist Health Medical Towers Pharmacy is recalling three Deferoxamine cassettes in Arkansas due to a lack of sterility assurance.

    Product
    Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1885-2016·2016-06-08

    Siemens Dimension Vista 500 Lab System Software Defect Recall

    Siemens recalls Dimension Vista 500 systems due to a software defect that may omit probe rinses, potentially causing discrepant patient results.

    Product
    Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures suc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2016·2016-06-08

    Fujifilm ED-250XL5 Endoscope Manual Correction for Infection Control

    Fujifilm Medical Systems is correcting the ED-250XL5 endoscope operations manual to address reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1409-2016·2016-06-08

    Giant Eagle Recalls Pecan Tassies Due to Undeclared Milk Allergen

    Giant Eagle is recalling Pecan Tassies because the packaging fails to declare milk as an ingredient or allergen.

    Product
    Pecan Tassie - 6 Pack PLU# 77997 Net Wt. 5 OZ. Sell By (dates up to) May 03, 2016 Giant Eagle, Inc., Pittsburgh, PA
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1407-2016·2016-06-08

    Blue Bell Rocky Road Ice Cream Recalled for Undeclared Wheat and Soy

    Blue Bell Creameries is recalling 23,973 pints of Rocky Road ice cream sold in Texas and Louisiana because the product may contain undeclared wheat and soy.

    Product
    BLUE BELL ICE CREAM Rocky Road pint
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1419-2016·2016-06-08

    Buddy Fruits Recalls Lemon Fruit Tartlets Due to Undeclared Milk

    Ouhlala Gourmet LLC is recalling lemon fruit tartlets because the finished product contains undeclared milk. The recall covers 9,159 cases distributed nationwide and internationally.

    Product
    Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g). Manufactured in France. Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1406-2016·2016-06-08

    Liquid Assets Recalls Life's Qik Fix 70 Plant Minerals Due to Undeclared Allergens

    Liquid Assets Inc is recalling Life's Qik Fix 70 Plant Minerals dietary supplements because they contain undeclared milk and soy.

    Product
    Life's Qik Fix 70 Plant Minerals Plus 80 Additional Nutrients 180 Vegetable Capsules Dietary Supplement Manufactured Exclusively For: MAGZUMA NUTRITION Overland Park, Kansas 66210 www.magzuma.com 1-888-306-8855 or 1-913-624-9676
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-1842-2016·2016-06-08

    ConMed Recalls Hip Preservation System PreBent Burs Due to Metal Shavings

    ConMed is recalling 991 Hip Preservation System PreBent Burs because an assembly error caused metal shavings to be released during use.

    Product
    Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The ConM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2016·2016-06-08

    Fujifilm ED-530XT Endoscope Manual Correction for Infection Control

    Fujifilm Medical Systems is correcting the ED-530XT endoscope manual to address reports of multi-drug resistant bacteria found on endoscopes used in ERCP procedures.

    Product
    Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1408-2016·2016-06-08

    Giant Eagle Walnut Delights Recalled for Undeclared Milk Allergen

    Giant Eagle is recalling Walnut Delights 6 Packs because the labels fail to declare the milk ingredient and allergen.

    Product
    Walnut Delights 6 Pack Net Weight: 9 oz. PLU #69690 UPC: 2 69690 20399 7 Giant Eagle, LLC, Pittsburgh, PA
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1420-2016·2016-06-08

    Ouhlala Gourmet Recalls Raspberry Fruit Tartlets for Undeclared Milk

    Ouhlala Gourmet is recalling raspberry fruit tartlets because the finished product labeling fails to declare milk as an ingredient.

    Product
    Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g). Manufactured in France. Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1405-2016·2016-06-08

    Angel Wings and Magzuma Supplements Recalled for Undeclared Milk and Soy

    Liquid Assets Inc. is recalling Angel Wings and Magzuma dietary supplements because they contain undeclared milk and soy allergens.

    Product
    Angel Wings Complete Daily Multi with 146 nutrients including Anti-aging and Superfruit Antioxidants and 75 Plant Derived Minerals 120 Capsules UPC: 0-16158-01225-3 Liquid Assets, Inc. Tulsa, OK 74116 1-888-497-4535 www.ExceptionalProducts.org; Magzuma Zuma Supreme Daily Wellness
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-1831-2016·2016-06-08

    Smiths Medical Recalls CADD Administration Sets with Flow Stop

    Smiths Medical is recalling CADD Administration Sets with Flow Stop because under-delivery of medication may occur. The recall affects 13,696,830 units distributed in the US and internationally.

    Product
    CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1864-2016·2016-06-08

    Fujifilm ED-450XL5 Endoscope Manual Correction for Infection Control

    Fujifilm Medical Systems is correcting the operation manual for the ED-450XL5 endoscope to address publicized reports of multi-drug resistant bacteria on endoscopes used for ERCP procedures.

    Product
    Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2016·2016-06-08

    Natus Medical Recalls Replacement HEPA Filters for Sterile-Driers

    Natus Medical is recalling 21 replacement HEPA filters for Sterile-Driers because improperly cured sealant may emit toxic gas or drip, contaminating the device.

    Product
    Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44. Filter Catalogue Part Number: 54343, 54344, and 100105-01.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-1316-2016·2016-06-08

    Frank L Harter & Sons Recalls Pasta Salad for Missing Allergen Labeling

    Frank L Harter & Sons Inc. is recalling 548 cases of 5 lb pasta salad containers because the labels failed to list milk and soy as ingredients.

    Product
    PASTA SALAD ING: PASTA, ITALIAN DRESSING, DRY ONIONS, PARSLEY, RED PEPPERS, PARMESON CHEESE, SPICES. CONTAINS MILK KEEP REFRIGERATED NET WEIGHT 5LB.(2.26KG.) F.L. HARTER & SONS INC. 3778 FRONDORF AVE. CINTI OH. 45211
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1836-2016·2016-06-08

    Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk

    Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.

    Product
    SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when th
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1315-2016·2016-06-08

    Frank L Harter & Sons Recalls Spinach Dip for Allergen Mislabeling

    Frank L Harter & Sons is recalling 5 lb containers of Spinach Dip because the label failed to list milk and soy as ingredients.

    Product
    SPINACH DIP ING: VEGETABLE SOUP MIX, MAYONAISE, SOUR CREAM, SPINACH, WATER CHESTNUTS, DRY ONIONS KEEP REFRIGERATED NET WT. 5LB. (KG) F.L.HARTER & SONS INC. CINCINNATI, OHIO 45211
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1902-2016·2016-06-08

    Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1900-2016·2016-06-08

    Exactech Recalls Three Ceramic Hip Acetabular Cups Due to Premature Packaging

    Exactech is recalling three Novation Ceramic AHS Cluster-Hole Shells because they were packaged before the required site-change approval was granted.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1865-2016·2016-06-08

    Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference

    Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.

    Product
    The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1874-2016·2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2016·2016-06-08

    Philips Ingenuity CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0950-2016·2016-06-08

    Taro Recalls Subpotent Topicort Cream Tubes in Multiple States

    Taro Pharmaceuticals is recalling 62,800 tubes of Topicort cream because the medication contained less active ingredient than labeled.

    Product
    ¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-520
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1843-2016·2016-06-08

    Medscience AllergiEnd Skin Test Applicators Recalled for Lack of Clearance

    Medscience Inc is recalling AllergiEnd ST-9 skin test applicators and trays because they were marketed without FDA clearance.

    Product
    AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1412-2016·2016-06-08

    O'Steen Meat Specialties Recalls Spicy Mac & Cheese Bites Due to Plastic Inclusion

    O'Steen Meat Specialties is recalling 847 cases of Spicy Mac & Cheese Bites because they may contain pieces of plastic. The product was distributed in seven states.

    Product
    Code 2013 Spicy Mac & Cheese Bites Breaded Macaroni & Monterey Jack Cheese O 'Steen Meat Specialties Inc. 2126 N. Broadway Oklahoma City, OK 73103 Phone (405) 236-1952 KEEP FROZEN Net Weight 10 LBS. UPC: 7-49616-02013-1
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1839-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2016·2016-06-08

    Leica Novocastr Antibody Recalled for Stability Issues

    Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1872-2016·2016-06-08

    Philips Brilliance 64 CT Systems Recalled for Software Mapping Error

    Philips Medical Systems is recalling 158 Brilliance 64 CT systems because the software may fail to map the Varian drive after a user logs out and back in.

    Product
    Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2016·2016-06-08

    Exactech Recalls One Novation Femoral Stem Device for Premature Packaging

    Exactech is recalling one Novation femoral stem device because it was packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1903-2016·2016-06-08

    Exactech Recalls One Novation Femoral Stem for Premature Packaging

    Exactech is recalling one Novation femoral stem device because it was packaged before the required FDA site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1901-2016·2016-06-08

    Exactech Recalls Two Novation Ceramic Hip Acetabular Cups

    Exactech is recalling two Novation Ceramic AHS Cluster-Hole Shell acetabular cups because they were packaged before regulatory approval.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1845-2016·2016-06-08

    Olympus Recalls Duodenoscopes for New Reprocessing Instructions

    Olympus Corporation of the Americas is recalling TJF-160F and TJF-160VF duodenoscopes to provide new reprocessing instructions and a cleaning brush.

    Product
    EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1873-2016·2016-06-08

    Philips Ingenuity Core CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 300 Ingenuity Core CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,128 COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2016·2016-06-08

    Exactech Recalls Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling nine Novation femoral stems because they were packaged before receiving FDA approval for a site change.

    Product
    Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1834-2016·2016-06-08

    MicroAire Pneumatic Impactor Recall for Missing Symbol Markings

    MicroAire is recalling 20 Pneumatic Impactor units because they are missing required lock and unlock symbol markings.

    Product
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1877-2016·2016-06-08

    Leica Microsystems Recalls Unstable CDX2 Antibody Lots

    Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-1906-2016·2016-06-08

    B. Braun Medical Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling approximately 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the product label.

    Product
    Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1909-2016·2016-06-08

    Affymetrix Recalls CytoScan Dx Assay Kits Due to Missing Warning Statements

    Affymetrix is recalling 507 CytoScan Dx Assay kits because FDA inspectors found that required warning statements were missing from product shipments.

    Product
    CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx P
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Drugs)·D-0953-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection vials because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0955-2016·2016-06-08

    Lupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations

    Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient because intermediates failed specifications.

    Product
    Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1907-2016·2016-06-08

    B. Braun Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the device.

    Product
    Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0951-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Ceftriaxone for Injection USP because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0952-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, because the active ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0954-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, because the active pharmaceutical ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·16V407000·2016-06-07

    Thomas Built Buses Recall Emergency Door Handle Corrosion Defect

    Daimler Trucks North America is recalling 717 Thomas Built Buses because corrosion on the emergency door handle stem could delay evacuation during an emergency.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES, THOMAS SAF-T-LINER MVP-EF, SAF-T-LINER ER, CL-960, VISTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16752·2016-06-07

    Focus Bicycles Recalls Spine Models Due to Frame Collapse Risk

    Focus Bicycles is recalling about 80 Spine mountain bicycles because incorrectly sized seatstay or linkage parts can cause the frame to collapse, posing a fall hazard.

    Product
    Focus Spine bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E052000·2016-06-06

    Meritor Recalls Front Axles Due to Potential Heat Treatment Defect

    Meritor is recalling specific FF967 Non-Drive Front Steer axles manufactured in 2012 because they may have been incorrectly heat treated, posing a risk of fracture and loss of vehicle control.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V404000·2016-06-06

    Lakota Recalls 2016 Trailers Due to Aluminum Rim Pin Holes

    Lakota is recalling 2016 Bighorn, Charger, and Livestock Edition trailers because pin holes in aluminum rims may cause tire failure and increase crash risk.

    Product
    LAKOTA — LAKOTA BIGHORN, LIVESTOCK EDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V403000·2016-06-06

    Volkswagen Recalls 2016 Jetta, Passat, and Golf for Fuel Rail Defect

    Volkswagen is recalling specific 2016 Jetta, Passat, and Golf vehicles because the fuel rail may detach, causing a fuel leak that could lead to a vehicle fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF, JETTA, PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V405000·2016-06-06

    Blue Bird Recalls Transit Buses with Defective Wheelchair Lifts

    Blue Bird is recalling 2015-2017 All American and 2016-2017 Vision transit buses equipped with Ricon S-Series wheelchair lifts due to potential platform cracking and bearing displacement.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·047-2016·2016-06-04

    Solomon Snacks Recalls Meat Pies for Undeclared Allergens and Lack of Inspection

    Solomon Snacks and Bakery is recalling approximately 873 pounds of meat pies produced without federal inspection and containing undeclared eggs, milk, and wheat.

    Product
    Solomon Snacks and Bakery Recalls Meat Pie Products Produced Without Benefit of Inspection and Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·16V400000·2016-06-03

    Spartan Gladiator and MetroStar Emergency Vehicles Recalled for Pump Defect

    Spartan is recalling 2015 Gladiator and MetroStar emergency vehicles because improperly soldered pump strainers may break, potentially damaging the pump and reducing firefighting effectiveness.

    Product
    SPARTAN — SPARTAN GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·046-2016·2016-06-03

    Butterfield Foods Recalls Broccoli Salad Kits Due to Listeria Risk

    Butterfield Foods is recalling broccoli salad kits in Indiana and Ohio due to possible Listeria contamination from sunflower kernels.

    Product
    Butterfield Foods, LLC — Butterfield Foods, LLC. Recalls Broccoli Salad Kit Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·16V401000·2016-06-03

    Chrysler Sebring and Dodge Stratus Recall for Sun Visor Tether Defect

    Mitsubishi is recalling 2001-2002 Chrysler Sebring and Dodge Stratus vehicles with beige interiors because an incorrect part may allow the passenger sun visor to detach during airbag deployment.

    Product
    CHRYSLER — CHRYSLER, DODGE SEBRING, STRATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V394000·2016-06-02

    Autocar Recalls 2016-2017 Xpeditor Trucks for Engine Stall Risk

    Autocar is recalling 18 Xpeditor trucks due to a defective engine control module that may cause the engine to stall unexpectedly, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V399000·2016-06-02

    West-Mark Recalls 2014-2015 Sugar Tank Trailers Due to Brake Drag

    West-Mark is recalling 2014-2015 Sugar Tank trailers because improperly seated brake diaphragms may cause drag, potentially leading to wheel end fires.

    Product
    WEST-MARK — WEST-MARK SUGAR TANK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V397000·2016-06-02

    Tiffin Allegro Motorhomes Recalled for Steering Box Wear Risk

    Tiffin is recalling 2014-2016 Allegro motorhomes because incorrect steering box spacers can cause premature wear, leading to a sudden loss of steering ability and increased crash risk.

    Product
    TIFFIN — TIFFIN ALLEGRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16751·2016-06-02

    Hillsdale Furniture Recalls Children's Bunk Beds Due to Fall Hazard

    Hillsdale Furniture is recalling about 20,000 children's bunk beds sold at Bob's Discount Furniture because support rails can crack or break, posing a fall hazard.

    Product
    Children's bunk beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V396000·2016-06-02

    Toyota Vehicles Recalled for Aftermarket Seat Heater Fire Risk

    Southeast Toyota Distributors is recalling specific Toyota vehicles equipped with aftermarket seat heaters due to a risk of electrical short circuits and fire.

    Product
    TOYOTA — TOYOTA CAMRY SOLARA, SEQUOIA, TACOMA, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V398000·2016-06-02

    Ameritrans 285 Shuttle Buses Recalled for Wheelchair Lift Defects

    Ameritrans is recalling 2015-2016 285 shuttle buses because wheelchair lift platform side plates may crack or bearings may shift, posing an injury risk.

    Product
    AMERITRANS — AMERITRANS 285
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16186·2016-06-02

    LaRose Recalls Cra-Z-Jewelz Jewelry Kits Due to Lead Violation

    LaRose Industries is recalling Cra-Z-Jewelz jewelry kits because the slider bracelet component contains high levels of lead, posing a health risk to young children.

    Product
    Cra-Z-Jewelz Gem Creations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V395000·2016-06-02

    Thomas Built Buses Recalled for Corroded Emergency Door Handle Stems

    Daimler Trucks North America is recalling specific Thomas Built Buses because corrosion on the emergency door handle stem may delay evacuation during an emergency.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES, THOMAS SAF-T-LINER FS65, VISTA, SAF-T-LINER MVP-ER, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0863-2016·2016-06-01

    Baxter Recalls Metronidazole Injection Bags Due to Cloth Fiber Particulate Matter

    Baxter Healthcare Corp. is recalling 334,560 bags of Metronidazole Injection USP due to the presence of a cloth fiber. The product was distributed nationwide and in Puerto Rico.

    Product
    METRONIDAZOLE — METRONIDAZOLE (METRONIDAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0873-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling 159,000 Auvi-Q epinephrine auto-injectors nationwide because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0894-2016·2016-06-01

    FDA Recalls Unapproved Male Enhancement Product Sold Nationwide Online

    The FDA is recalling 'Bigger Longer More Time More Sperms' because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0877-2016·2016-06-01

    Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients

    Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1377-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Ingredients

    The Sausage Maker, Inc. is recalling Dried Sausage Sticks seasoning because the Fermento ingredient contains undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Dried Sausage Sticks under the following labels: 1) Net Wt 6.5 oz, 2) Net Wt 2 lbs, 3) Net Wt 25 lbs, 4) Dried Sausage Stick Kit, 5) Dried Sticks Assortment Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0881-2016·2016-06-01

    FDA Recalls Weight Loss Product Containing Undeclared Sibutramine and Phenolphthalein

    Lucy's Weight Loss System is recalling Shorts on The Beach Golden Edition because it contains undeclared sibutramine and phenolphthalein.

    Product
    Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0880-2016·2016-06-01

    FDA Recalls Weight Loss Capsules Containing Undeclared Sibutramine and Phenolphthalein

    Lucy's Weight Loss is recalling Shorts on The Beach Strong Formula capsules nationwide because they contain undeclared sibutramine and phenolphthalein.

    Product
    Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0900-2016·2016-06-01

    Hard Ten Days capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Hard Ten Days capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0888-2016·2016-06-01

    Weekend Prince capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Weekend Prince capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0897-2016·2016-06-01

    Germany Niubian Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Germany Niubian capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0864-2016·2016-06-01

    Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter

    Baxter Healthcare is recalling 7,436 bags of Clinimix E injection due to the presence of dried skin particulate matter. The product was distributed nationwide and in Puerto Rico.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0887-2016·2016-06-01

    FDA Recalls Stree Overlord Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Stree Overlord capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0905-2016·2016-06-01

    FDA Recalls Samurai-X Capsules Marketed Without Approval

    R Thomas Marketing, LLC is recalling Samurai-X capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1382-2016·2016-06-01

    Sausage Maker Seasoning Recalled for Undeclared Milk Allergens

    The Sausage Maker, Inc. is recalling Trail Bologna seasoning because it contains undeclared whey protein and skim milk powder.

    Product
    THE SAUSAGE MAKER SEASONING Trail Bologna under the following labels: 1) Net Wt 2 lbs. 8 oz, 2) Net Wt 25 lbs, 3) Trail Bologna Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0869-2016·2016-06-01

    Avastin Syringes Recalled for Bacterial Contamination

    AmEx Pharmacy is recalling 45 Avastin syringes nationwide because testing revealed bacterial contamination.

    Product
    Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0883-2016·2016-06-01

    Shorts on the Beach capsules recalled for undeclared dangerous ingredients

    Lucy's Weight Loss System is recalling Shorts on the Beach capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.

    Product
    Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0908-2016·2016-06-01

    Licorice Coughing Liquid Recalled for Undeclared Morphine

    Master Herbs is recalling Licorice Coughing Liquid because it contains undeclared morphine and was marketed without an approved NDA or ANDA.

    Product
    Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0895-2016·2016-06-01

    FDA Recalls Black Ant King for Lack of Approved New Drug Application

    R Thomas Marketing, LLC is recalling Black Ant King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0904-2016·2016-06-01

    Tiger King capsules recalled for lack of FDA approval

    R Thomas Marketing, LLC is recalling Tiger King capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0878-2016·2016-06-01

    Smart Lipo Dietary Supplement Recalled for Undeclared Dangerous Ingredients

    Centro Naturista is recalling Smart Lipo Dietary Supplement capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

    Product
    Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0882-2016·2016-06-01

    Pink Bikini capsules recalled for undeclared dangerous ingredients

    Lucy's Weight Loss System is recalling Pink Bikini capsules because they contain undeclared Sibutramine, Phenolphthalein, and/or Diclofenac.

    Product
    Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
    Category
    Drug
    Distribution
    Distributed nationwide

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