The Recall Desk

Archive

August 2012 recalls

875 recalls were announced in August 2012.

What the numbers show

Critical
155
Severe
348
High
251
Moderate
101
Low
20

Of the 875 recalls this month scored against our rubric, 18% are Critical, 40% are Severe.

Which agencies issued them

601–700 of 875

  • HighFDA (Devices)·Z-2176-2012·2012-08-15

    Stryker Spine Recalls Reliance AL Implant Blocker Due to Prong Breakage

    Stryker Spine is recalling Reliance AL Implant Blockers because six reports indicated that prongs on the instruments broke during use.

    Product
    Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2012·2012-08-15

    Abbott i-Stat CK-MP Cartridges Recalled for Atmospheric Pressure Interference

    Abbott Point of Care Inc. is recalling i-Stat CK-MP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting the diagnosis of myocardial infarction.

    Product
    i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myo
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1557-2012·2012-08-15

    River Ranch Spring Mix Recalled for Listeria monocytogenes Contamination

    River Ranch Fresh Foods is recalling Spring Mix salad bags because FDA samples tested positive for Listeria monocytogenes.

    Product
    River Ranch brand Spring Mix, 24 oz bag, 48 oz bag, UPCs: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Fo
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1616-2012·2012-08-15

    River Ranch Recalls Fresh n Easy Shredded Green Cabbage Due to Listeria

    River Ranch Fresh Foods is recalling Fresh n Easy brand shredded green cabbage because samples tested positive for Listeria monocytogenes.

    Product
    Fresh n Easy brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fr
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2141-2012·2012-08-15

    Baxter Recalls Automix 3+3 Compounder Systems Due to Electrical Failures

    Baxter Healthcare is recalling 3,106 Automix 3+3 Compounder Systems because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1593-2012·2012-08-15

    River Ranch Shredded Green Cabbage Recalled for Listeria Contamination

    River Ranch Fresh Foods is recalling shredded green cabbage with carrots due to Listeria monocytogenes contamination found in FDA-pulled samples.

    Product
    River Ranch brand Shred Grn Cabb w/Carr, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh F
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1609-2012·2012-08-15

    River Ranch Recalls Cross Valley Shredded Green Cabbage for Listeria

    River Ranch Fresh Foods is recalling Cross Valley brand Shredded Green Cabbage due to Listeria monocytogenes contamination found in FDA-pulled samples.

    Product
    Cross Valley brand Shred Grn Cabbage w/Color, 4 x 5 lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fr
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2142-2012·2012-08-15

    Baxter Recalls Automix 3+3 Compounders Due to Electrical Failures

    Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1545-2012·2012-08-15

    River Ranch Angel Hair Salad Recalled for Listeria monocytogenes

    River Ranch Fresh Foods is recalling Angel Hair salad due to Listeria monocytogenes contamination found in FDA samples.

    Product
    River Ranch brand Angel Hair, 10 oz bag, UPC: 45388-10031;Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, L
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2172-2012·2012-08-15

    Siemens EasyLink Informatics System Recalled for Incorrect Diagnostic Results

    Siemens Healthcare Diagnostics is recalling 237 EasyLink Informatics Systems because they may display and transmit incorrect results to Laboratory Information Systems when used with specific coagulation analyzers.

    Product
    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1845-2012·2012-08-15

    Punjabi Cookies Recalled for Undeclared Milk Allergen

    Nuts and Spice Co. is recalling Punjabi Cookies due to potential undeclared milk. The product was distributed in Northern California and parts of the West.

    Product
    CRISPY Just Baked Punjabi Cookies by TWI Foods, Net Wt 800 gr, (1.76 lbs, 28.2 oz). Product of Canada Manufactured by TWI Foods, Mississauga, Ontario, Canada.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-1442-2012·2012-08-15

    Teva Recalls Copaxone Injections Due to Foreign Particle Presence

    Teva Pharmaceuticals is recalling specific lots of Copaxone (glatiramer acetate) injection due to the presence of a foreign particle identified from a customer complaint.

    Product
    COPAXONE — COPAXONE (GLATIRAMER ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1859-2012·2012-08-15

    Tres Monjitas Tropical Splash Guanabana Recalled for Undeclared Allergens

    Altura Food, Inc. is recalling 9,528 bottles of Tres Monjitas Tropical Splash Guanabana because the product contains undeclared allergens: hydrogenated coconut oil, sodium caseinate, and soy lecithin.

    Product
    "***Tres Monjitas***Tropical Splash***Guanabana***15 oz***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1927-2012·2012-08-15

    Designer Whey French Vanilla Protein Powder Recalled for Gluten

    Designer Protein LLC is recalling Designer Whey French Vanilla protein powder because lab results confirmed the presence of gluten in products labeled gluten-free.

    Product
    Designer Whey French Vanilla, 2lbs, item # 10200133, 4 units/case. UPC 8-44334-00133-9. Designer Whey French Vanilla, 3lbs, Item#10200134, 5 units/case. UPC 8-4434-00133-10.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1575-2012·2012-08-15

    River Ranch Recalls Farmers Market Cole Slaw Due to Listeria Risk

    River Ranch Fresh Foods is recalling The Farmers Market brand Cole Slaw because FDA samples tested positive for Listeria monocytogenes.

    Product
    The Farmers Market brand Cole Slaw, 16 oz bag, UPC: 30034-30013; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2157-2012·2012-08-15

    Abbott i-STAT PT/INR Cartridges Recalled for Incorrectly Elevated Results

    Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated results, potentially affecting monitoring of patients on anticoagulation therapy.

    Product
    I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2012·2012-08-15

    Abbott i-Stat BNP Cartridges Recalled for Atmospheric Pressure Interference

    Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.

    Product
    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2177-2012·2012-08-15

    Terumo Advanced Perfusion System 1 Recall for Module Malfunctions

    Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the oper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1581-2012·2012-08-15

    River Ranch Recalls Parisian Salad Blend Due to Listeria Risk

    River Ranch Fresh Foods is recalling The Farmers Market brand Parisian Salad Blend because samples tested positive for Listeria monocytogenes.

    Product
    The Farmers Market brand Parisian Salad Blend, 7 oz bag, UPC: 30034-30259; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ra
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2149-2012·2012-08-15

    Apheresis Technologies Recalls Plasma Pump Model PP-04a Due to Rotor Failure

    Apheresis Technologies is recalling 13 Plasma Pump Model PP-04a units because a rotor stopped during treatment, interrupting flow.

    Product
    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1560-2012·2012-08-15

    Hy Vee Cole Slaw Recalled Due to Listeria monocytogenes Contamination

    River Ranch Fresh Foods is recalling Hy Vee brand Cole Slaw because samples tested positive for Listeria monocytogenes.

    Product
    Hy Vee brand Cole Slaw, 16 oz bag, UPC: 75450-12051; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2178-2012·2012-08-15

    Terumo Advanced Perfusion System 1 recalled for module malfunctions

    Terumo is recalling 649 Advanced Perfusion System 1 units worldwide due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the oper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2012·2012-08-15

    Siemens syngo Lab Data Manager Recall for Incorrect Coagulation Results

    Siemens is recalling 15 syngo Lab Data Manager units because they may display and transmit incorrect coagulation results to laboratory information systems.

    Product
    Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2012·2012-08-15

    Biomet 3i Recalls Dental Implants Due to Shallow Internal Hex Depth

    Biomet 3i is recalling specific dental implants because the internal hex depth is too shallow, which may prevent components from fully engaging the implant.

    Product
    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1570-2012·2012-08-15

    River Ranch Recalls Shurfresh Greener Garden Salad Due to Listeria

    River Ranch Fresh Foods is recalling Shurfresh brand Greener Garden Salad because samples tested positive for Listeria monocytogenes.

    Product
    Shurfresh brand Greener Garden Salad, 12 oz bag, UPC: 11161-40133; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fres
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1842-2012·2012-08-15

    Punjabi Cookies Recalled for Potential Undeclared Milk Allergen

    Shah Distributors is recalling CRISPY Just Baked Punjabi Cookies because they may not declare milk as an ingredient.

    Product
    CRISPY Just Baked Punjabi Cookies 800 g/1.76 lb (28.2 oz): Product of Canada Manufactured by: TWIK Foods Inc. Mississauga, ON, Canada.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1909-2012·2012-08-15

    Trader Joe's Diced Onions, Garlic & Shallots Recalled for Listeria

    GH Foods CA LLC is recalling Trader Joe's Diced Onions, Garlic & Shallots because the onions used in the product were recalled for Listeria monocytogenes.

    Product
    Trader Joe's Diced Onions, Garlic & Shallots; 2 lb package. Manufactured by GH Foods CA LLC, Rancho Cordova, CA.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2153-2012·2012-08-15

    Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import

    Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.

    Product
    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2012·2012-08-15

    Kimberly-Clark Patient Warming System Recalled for Fuse Holder Defect

    Kimberly-Clark is recalling 129 Model 1000 Patient Warming System Control Units because a fuse holder defect may cause the device to fail or generate smoke.

    Product
    Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2012·2012-08-15

    Tango3 Water Storage Tank Recalled for Quality System Deficiencies

    Tango3 LLC is recalling 44 water storage tanks with ozone disinfection systems due to quality system deficiencies and lack of assurance that systems operate at minimum ozone levels.

    Product
    TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water dis
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Food)·F-1582-2012·2012-08-15

    River Ranch Recalls Angel Hair Cole Slaw Due to Listeria

    River Ranch Fresh Foods is recalling The Farmers Market brand Angel Hair Cole Slaw because samples tested positive for Listeria monocytogenes.

    Product
    The Farmers Market brand Angel Hair Cole Slaw, 10 oz bag, UPC: 30034-30266; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River R
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1574-2012·2012-08-15

    River Ranch Recalls Sysco Spring Mix Due to Listeria Risk

    River Ranch Fresh Foods is recalling Sysco brand Spring Mix because samples tested positive for Listeria monocytogenes.

    Product
    Sysco brand Spring Mix, 48 oz bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2179-2012·2012-08-15

    Medical Specialties Distributors Recalls Leaking Medstream Infusion Sets

    Medical Specialties Distributors is recalling Medstream 81-inch infusion sets that may leak at the Y-site. The recall covers 472 cases distributed nationwide.

    Product
    Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2012·2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Potential Breakage

    Smith & Nephew is recalling 2,204 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1592-2012·2012-08-15

    River Ranch Shredded Green Cabbage Recalled for Listeria Contamination

    River Ranch Fresh Foods LLC is recalling Shredded Green Cabbage with Color due to Listeria monocytogenes contamination found in FDA samples.

    Product
    River Ranch brand Shred Grn Cabbage w/Color, 4 x 5lb bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fres
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1585-2012·2012-08-15

    River Ranch Garden Salad Recalled Due to Listeria Contamination

    River Ranch Fresh Foods is recalling The Farmers Market brand Garden Salad because samples tested positive for Listeria monocytogenes.

    Product
    The Farmers Market brand Garden Salad, 6 oz, 12 oz, 24 oz bags, UPCs: 30034-30012, 30034-30400, 30034-30363; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2140-2012·2012-08-15

    Baxter Recalls Automix Plus High Speed Compounder Systems

    Baxter Healthcare is recalling 840 Automix Plus High Speed Compounder Systems due to electrical failures that may cause incorrect responses or undetected stops.

    Product
    AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2012·2012-08-15

    ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter

    ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter was 4.5mm instead of the intended 3.5mm.

    Product
    PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1925-2012·2012-08-15

    Maya Kaimal Coconut Curry Simmer Sauce Recalled for Bloated Containers

    Two Chefs On A Roll, Inc. is recalling Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce due to bloated containers. The product was distributed to accounts in eight northeastern states.

    Product
    Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2156-2012·2012-08-15

    Philips MultiDiagnost Eleva X-ray System Recalled for 3D Reconstruction Failure

    Philips Healthcare Inc. is recalling 41 units of the MultiDiagnost Eleva X-ray system because the 3D reconstruction feature may fail to start during rotational angiography.

    Product
    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1443-2012·2012-08-15

    Apotex Recalls Meloxicam Tablets Due to Slightly Oversized Tablet

    Apotex Corp. is recalling 1,749 bottles of Meloxicam 15 mg tablets because one bottle contained a slightly oversized tablet.

    Product
    Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2012·2012-08-15

    SCC Soft Computer Recalls SoftLab Laboratory Information System Software

    SCC Soft Computer is correcting SoftLab software versions that incorrectly displayed results from two different Sysmex hematology instruments under a single order.

    Product
    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1929-2012·2012-08-15

    Great American Seafood Cooked Shrimp Meat Recalled for Undeclared Dyes

    Southwind Foods is recalling cooked shrimp meat because it contains undeclared red #40 and yellow #6 colors.

    Product
    Great American Seafood Imports Co. Cooked Shrimp Meat. Size: 300/500 count per pound in 2-lb (item #06834) and 5-lb (Item #07756) packages.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2012·2012-08-15

    Radiometer ABL Software Recall for HL7 Data Transmission Errors

    Radiometer America Inc. is recalling ABL software version 6.12 for ABL800 and ABL700 analyzers because HL7 2.5 data transmission errors can mix up queued results.

    Product
    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2012·2012-08-15

    Afassco Multi-Colored Finger Cots Recalled for Missing Latex Warning Label

    Afassco Inc. is voluntarily correcting a field issue for multi-colored finger cots that lack the required natural rubber latex warning label.

    Product
    The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable produ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2161-2012·2012-08-15

    Straumann Dental Implant Screw Recall Due to Incorrect Component

    Straumann USA is recalling 14 dental implant sets because the included screw was not the correct Narrow CrossFit model.

    Product
    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2012·2012-08-15

    Smith & Nephew Dyonics Electroblade Resector Recalled for Labeling Error

    Smith & Nephew is recalling Dyonics Electroblade Resectors labeled with an incorrect 48-month expiry date instead of 36 months.

    Product
    Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2012·2012-08-15

    Abbott i-Stat cTnl Cartridges Recalled Due to Atmospheric Pressure Effects

    Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.

    Product
    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis a
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1858-2012·2012-08-15

    Naturex Recalls Dried Brewers Yeast Due to High Selenium Levels

    Naturex Inc. is recalling specific lots of Dried Brewers Yeast because testing found unusually high levels of selenium. The product was distributed to two firms in New Jersey and South Carolina.

    Product
    Dried Brewers Yeast TG_YFS004 Naturex 375 Huyler Street, South Hackensack, NJ 07606 USA Phone: 1 201 440 5000 Net Wt 25 kg
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2146-2012·2012-08-15

    Encore Medical Recalls Mislabelled 6.5 mm Cancellous Bone Screws

    Encore Medical is recalling 18 bone screws because the package label incorrectly states the size is 30mm, while the actual screw dimension is 25mm.

    Product
    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2012·2012-08-15

    Radiometer ABL800 Software Recall for HL7 Data Transmission Errors

    Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.

    Product
    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2180-2012·2012-08-15

    AngioDynamics Recalls Soft-Vu Angiographic Catheters Due to Mislabeled Pouches

    AngioDynamics is recalling one lot of Soft-Vu angiographic catheters because a pouch inside the box may be mislabeled.

    Product
    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2145-2012·2012-08-15

    Smith & Nephew Dyonics Bonecutter Recalled for Incorrect Expiry Labeling

    Smith & Nephew is recalling 108 units of the 5.5 mm Dyonics Bonecutter because the devices are labeled with a 48-month expiry instead of the validated 36-month period.

    Product
    Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is eff
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2012·2012-08-15

    Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Testing Failures

    Oklahoma Respiratory Care Inc is recalling 861 cylinders of compressed oxygen due to missing identity and purity testing and documentation gaps.

    Product
    OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1688-2012·2012-08-15

    Itoen Green Tea Recalled Due to Unretorted Product Release

    Itoen (USA) Inc. is recalling Itoen Green Tea cans because unretorted product was inadvertently released for distribution in California.

    Product
    Itoen Green Tea 11.5 fl oz (340 mL) can. Natural Source of Antioxidants; 0 calories, no sugar: ITO-EN USA Inc. 125 Puuhale Road Honolulu, HI 96819
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2154-2012·2012-08-15

    Greiner Bio-One Recalls Coagulation Blood Collection Tubes Due to Concentration Error

    Greiner Bio-One is recalling specific lots of 3mL coagulation blood collection tubes because a lower citrate concentration may cause falsely low test results.

    Product
    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2012·2012-08-15

    ConMed Linvatec Recalls CrossFT Punch Due to Incorrect Etching

    ConMed Linvatec is recalling 2 units of the CrossFT Punch (Lot #156920) because the device may have incorrect item numbers and depth lines.

    Product
    CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2148-2012·2012-08-15

    Berchtold Chromovision HD Wireless Camera Recall for Loose Wire Connections

    Berchtold Corp. is recalling 17 Chromovision HD Wireless Cameras because loose wire connections may cause image distortion or loss during surgical procedures.

    Product
    Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2159-2012·2012-08-15

    Roche Recalls Cobas KRAS Mutation Test Kits Due to Stability Concerns

    Roche Molecular Systems is recalling specific lots of the Cobas KRAS Mutation Test because stability testing showed the kits trended toward the upper specification limit for codon 61 peak height ratio.

    Product
    Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from form
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2152-2012·2012-08-15

    Impact Instrumentation Recalls Ten Model 731 EMV+ Uni-Vent Devices

    Impact Instrumentation is recalling ten Model 731 EMV+ Uni-Vent devices shipped before verification of a new integrated circuit was completed.

    Product
    Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2175-2012·2012-08-15

    Siemens Recalls Dimension Vista Vancomycin Reagent Cartridges

    Siemens is recalling Dimension Vista Vancomycin Reagent Cartridges because calibration failures prevent the vancomycin assay from running.

    Product
    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
    Category
    Medical Device
    Distribution
    39 states
  • SevereNHTSA·12V403000·2012-08-14

    Navistar Recalls 2011-2013 International Trucks for Brake Caliper Bolt Defect

    Navistar is recalling certain 2011-2013 International trucks because brake caliper bolts may be loose, increasing stopping distance or causing a pull during braking.

    Product
    INTERNATIONAL — INTERNATIONAL WORKSTAR, TRANSTAR, PROSTAR, DURASTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V397000·2012-08-14

    Suzuki Recalls Forenza and Reno Vehicles for Headlamp Wiring Defect

    Suzuki is recalling 2004-2006 Forenza and 2005-2006 Reno vehicles because poor wire contact can melt headlamp connections, causing loss of lights and increased crash risk.

    Product
    SUZUKI — SUZUKI FORENZA, RENO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12245·2012-08-14

    Toysmith Recalls Animal Snap Bracelets Due to Laceration Hazard

    Toysmith is recalling Animal Snap Bracelets because the metal snap band can wear through the fabric, exposing sharp edges that pose a laceration hazard.

    Product
    Animal Snap Bracelet
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V404000·2012-08-14

    Turtle Top Transit Buses Recalled for Wheelchair Lift Latch Defect

    Turtle Top is recalling 2006-2010 transit buses with specific wheelchair lifts because roll stop latches may bend, posing a fall risk to occupants.

    Product
    TURTLE TOP — TURTLE TOP TERRA TRANSPORT, FORD VAN TERRA, FORD ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V398000·2012-08-14

    Nissan Recalls 2013 Infiniti JX35 for Fuel Gauge Inaccuracy

    Nissan is recalling 7,842 2013 Infiniti JX35 vehicles because a misrouted fuel tube may cause the fuel gauge to read higher than the actual level, increasing the risk of stalling.

    Product
    INFINITI — INFINITI JX35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·12246·2012-08-14

    Canon Recalls EOS Rebel T4i Cameras Due to Allergic Reaction Risk

    Canon is recalling EOS Rebel T4i digital cameras because a chemical in the rubber grips can cause skin irritation. Consumers should stop using the cameras and contact Canon for free replacement grips.

    Product
    EOS Rebel T4i Digital SLR Cameras
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V396000·2012-08-10

    B & M Recalls 2012 HAUL-RITE Boat Trailers Due to Wheel Torque Defect

    B & M Manufacturing is recalling 2012 HAUL-RITE boat trailers because improperly specified wheels may not tighten correctly, risking wheel separation.

    Product
    HAUL-RITE — HAUL-RITE ABT78-TDM, ABT66-TDM, TRN63-HD, ABT78-HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12E029000·2012-08-10

    Valeo Recalls Engine Cooling Fans for Certain BMW Models

    Valeo is recalling aftermarket engine cooling fans for specific BMW models because a component may overheat and cause a fire.

    Product
    BMW — BMW 3 SERIES, 5 SERIES, 6 SERIES, 7 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V392000·2012-08-10

    Ducati Recalls 2012-2013 1199 Panigale Motorcycles for Fire Risk

    Ducati is recalling 2012-2013 1199 Panigale motorcycles because the exhaust butterfly valve bowden cable cover could melt or burn, leading to smoke or fire.

    Product
    DUCATI — DUCATI 1199 PANIGALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·12244·2012-08-09

    GE Recalls Dishwashers Due to Electrical Fire Hazard

    GE is recalling approximately 1.3 million dishwashers sold between 2006 and 2009 because an electrical failure in the heating element can cause fires.

    Product
    GE, GE Adora™, GE Eterna™, GE Profile™ and Hotpoint®, Dishwashers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12E028000·2012-08-09

    Mercedes-Benz Recalls Accessory Floor Mats for ML-Class Vehicles

    Mercedes-Benz is recalling accessory all-season floor mats for 2012-2013 ML-Class vehicles because they may trap the gas pedal, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ ML550, ML350, AMG ML63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2091-2012·2012-08-08

    Zimmer Recalls Nextgen Knee Instruments Due to Spring Clip Fracture Risk

    Zimmer Inc. is recalling 1,662 Nextgen Complete Knee Solution Femoral and Provisional Impactor/Extractor instruments because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.

    Product
    Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V388000·2012-08-08

    GM Recalls 2003-2004 Chevrolet Express and GMC Savana for Fuel Leak Risk

    General Motors is recalling 2003-2004 Chevrolet Express and GMC Savana vans in specific states due to a fuel filler pipe corrosion issue that could cause a fire.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1429-2012·2012-08-08

    Eagle Pharmaceuticals Recalls Argatroban Injection Due to Visible Particulates

    Eagle Pharmaceuticals is recalling specific lots of Argatroban Injection after a hospital reported crystalline particulates and fibers in a vial.

    Product
    Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1809-2012·2012-08-08

    Andante Dairy Cheese Recalled for Lack of Proper Pasteurization

    Andante Dairy is recalling multiple lots of cheese due to a lack of proper pasteurization, which could allow dangerous pathogens to survive.

    Product
    Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on packaged. Varieties include: Largo, a triple-creme cow's milk, and Picolo, a triple-creme cow's milk. Also made with cow's milk: Pianoforte,
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2113-2012·2012-08-08

    Sunrise Medical Recalls Padded Swing Away Arm Rests Due to Injury Reports

    Sunrise Medical is recalling 14,035 Padded Swing Away Arm Rests for specific wheelchair models because reports indicate injury when the armrest is used to support full body weight.

    Product
    Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1435-2012·2012-08-08

    Dr. Reddy's Ciprofloxacin Tablets Recalled for Foreign Tablet Contamination

    Dr. Reddy's is recalling Ciprofloxacin Tablets due to complaints of mislabeled bottles containing foreign tablets.

    Product
    Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V390000·2012-08-08

    Altec Aerial Device Vehicles Recalled for Steering Defect

    Altec is recalling 2012 aerial device vehicles because a torsion bar issue may cause steering deviation over bumps, increasing crash risk.

    Product
    ALTEC — ALTEC AT235P, AT37-G, AT235, AT200A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2012·2012-08-08

    Bayer Recalls Estradiol Hemihydrate Powder Due to Cross Contamination

    Bayer HealthCare Pharmaceuticals is recalling Estradiol Hemihydrate M20 EP/USP Powder due to cross contamination with another product. The affected lot was distributed in Kansas and California.

    Product
    Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1820-2012·2012-08-08

    Spillson's Big Sicilian Sandwich Recalled for Undeclared Yellow #5

    Spillson's, Ltd. is recalling 17 units of The Big Sicilian Sandwich due to undeclared Yellow #5 in the pepper ingredient, posing a risk to sensitive individuals.

    Product
    Spillson's Ltd. The Big Sicilian Sandwich Nt. Wt. 7oz
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·12V389000·2012-08-08

    Winnebago and Itasca Motor Homes Recalled for Propane Tubing Defect

    Winnebago is recalling 2012-2013 motor homes because scored copper propane tubing may fail, risking fire or explosion.

    Product
    ITASCA — ITASCA, WINNEBAGO REYO, SUNOVA, COMMERCIAL VEHICLE, VIEW PROFILE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12T021000·2012-08-08

    Hercules Recalls H502 Truck Tires Due to Sidewall Separation Risk

    Hercules Tire & Rubber Company is recalling specific H502 truck tires due to a manufacturing defect that may cause sidewall separation and increase crash risk.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1434-2012·2012-08-08

    Dr. Reddy's Recalls Amlodipine and Benazepril Capsules Due to Foreign Tablets

    Dr. Reddy's is recalling Amlodipine Besylate and Benazepril Hydrochloride capsules because bottles were mislabeled and contained foreign Ciprofloxacin tablets.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2092-2012·2012-08-08

    Zimmer Recalls Nextgen Knee Replacement Jaw Instruments Due to Fracture Risk

    Zimmer Inc. is recalling Nextgen Complete Knee Solution replacement jaws because the spring clip may fracture or fall off during use, potentially leaving fragments in the surgical site.

    Product
    Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1836-2012·2012-08-08

    JFC International Recalls Oyster Products Due to Insanitary Conditions

    JFC International is recalling several frozen oyster products because they were prepared or packed under insanitary conditions, posing a potential health risk.

    Product
    PAFCO Oyster Meat Tiny IQF, 40/8 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1440-2012·2012-08-08

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1428-2012·2012-08-08

    Zydus Recalls Metformin Tablets Due to Foreign Substance Presence

    Zydus Pharmaceuticals is recalling 1,176 bottles of Metformin Hydrochloride 1000 mg tablets because a pharmacist reported brown specks and metal shavings on the tablets.

    Product
    Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
    Category
    Drug
    Distribution
    Distributed nationwide

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