The Recall Desk

Archive

September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical
15
Severe
203
High
216
Moderate
81
Low
15

Of the 530 recalls this month scored against our rubric, 3% are Critical, 38% are Severe.

Which agencies issued them

101–200 of 530

  • HighFDA (Food)·F-1884-2013·2013-09-25

    Tasty Bake Frozen Dough Balls Recalled for Cryptosporidium Contamination Risk

    Tasty Bake Inc. is recalling frozen dough balls processed with Baker City, Oregon water due to potential Cryptosporidium contamination following a local boil water notice.

    Product
    Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 04018 9; Item # 00518 is 17 oz white dough ball, Winco brand, individually…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2233-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2199-2013·2013-09-25

    Tornier Recalls Aequalis Reversed II and Fracture Impactors

    Tornier is voluntarily recalling Aequalis Reversed II and Fracture Impactors because the tip may separate during surgery.

    Product
    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025.…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-1899-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake for Undeclared Food Dyes

    Jean's Cake is recalling Coffee Cake: queso crema (creme cheese) due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    Coffee Cake: queso crema (creme cheese)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2225-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1901-2013·2013-09-25

    Jean's Cake Recalls Coffee Cake Due to Undeclared Allergens

    Jean's Cake is recalling Coffee Cake: queso/manzana (cheese/apple) because it contains undeclared Yellow #5 and Yellow #6.

    Product
    Coffee Cake: queso/manzana (cheese/apple)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2221-2013·2013-09-25

    Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra HA Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling 708 TWINFIX Ultra HA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1896-2013·2013-09-25

    General Mills Recalls Pillsbury Cinnamon Rolls Due to Plastic Fragments

    General Mills is recalling specific cans of Pillsbury Cinnamon Rolls with Icing because the dough may contain fragments from a broken piece of plastic on the production line.

    Product
    Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12.4 oz and 2-pack USPC 1800045675,2- 12.4 oz (351 G) CANS, NET WT 24.8 OZ (1 LB 8.8 OZ 703 G.
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-2230-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2013·2013-09-25

    Smith & Nephew Recalls RAPTORMITE Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling RAPTORMITE 3.7 mm PLLA suture anchors because pinholes in primary pouches may breach the sterile barrier.

    Product
    RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2013·2013-09-25

    Smith & Nephew Recalls TWINFIX Ultra Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling TWINFIX Ultra suture anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2013·2013-09-25

    GE Healthcare Recalls CARESCAPE Monitor B850 for Alarm Priority Issue

    GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.

    Product
    GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2204-2013·2013-09-25

    Camlog USA Recalls Uncleared Dental Implant Abutments in Four States

    Camlog USA is recalling one unit of a CONELOG Titanium Base dental implant abutment because it was not cleared for sale or use in the United States.

    Product
    C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2259-2013·2013-09-25

    Kerr Recalls NX3 Try-In Gel Due to Material Mismatch

    Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel because some syringes contain a different material than the labeled shade.

    Product
    NX3 Try-In Gel. The product is used as a tooth shade resin material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2013·2013-09-25

    Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

    Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.

    Product
    Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2206-2013·2013-09-25

    Camlog USA Recalls Uncleared Dental Implant Abutments

    Camlog USA is recalling three units of CONELOG Titanbasis CAD/CAM titanium base abutments because the product was not cleared for sale or use in the United States.

    Product
    C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2203-2013·2013-09-25

    Camlog USA Recalls Uncleared Dental Implant Abutments in Four States

    Camlog USA is recalling two units of CONELOG Titanium Base CC dental implant abutments because the product was not cleared for sale or use in the United States.

    Product
    C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1883-2013·2013-09-25

    New Dream Team Recalls Fresh Basil Due to Pesticide Violations

    New Dream Team is recalling fresh sweet and Thai basil from Hawaii after state testing found pesticides not allowed on the crop.

    Product
    Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc. HI
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2258-2013·2013-09-25

    Spine Smith VisuALIF PEEK Block Recall Due to Potential Sizing Mislabeling

    Spine Smith Holdings is recalling 32 VisuALIF PEEK blocks because they may be marked as Medium when they are actually Small.

    Product
    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2198-2013·2013-09-25

    Assuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues

    Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.

    Product
    ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2211-2013·2013-09-25

    Implantech Recalls Terino Square Chin-Style II-Medium Implants

    Implantech Associates Inc is voluntarily recalling 8 units of Terino Square Chin-Style II-Medium implants because they do not meet dimensional requirements.

    Product
    Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2013·2013-09-25

    Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features

    Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.

    Product
    Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2013·2013-09-25

    Assuramed Recalls Hemoccult II SENSA elite Fecal Occult Blood Test Kits

    Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.

    Product
    Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2218-2013·2013-09-25

    Smith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach

    Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in the primary pouches may breach the sterile barrier.

    Product
    BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2253-2013·2013-09-25

    GE Healthcare Recalls Discovery IGS 730 X-Ray Systems for Boot Failure

    GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.

    Product
    GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1056-2013·2013-09-25

    Vicks NyQuil Liquid Recalled for Incorrect Undeclared Excipients Labeling

    Procter & Gamble is recalling Vicks NyQuil Cold and Flu Nighttime Relief Liquid Twin Packs because the outer wrap incorrectly identifies color additives.

    Product
    Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2205-2013·2013-09-25

    Camlog Dental Implant Abutments Recalled for Lack of FDA Clearance

    Camlog USA is recalling six dental implant abutments because they were not cleared for sale or use in the United States.

    Product
    C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2254-2013·2013-09-25

    Access Scientific Recalls Mislabeled POWERWAND Safety Introducer Catheters

    Access Scientific is recalling 160 units of the POWERWAND Safety Introducer with Extended Dwell Catheter because the product is mislabeled.

    Product
    POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2212-2013·2013-09-25

    Zeppessis Reprocessed Manifolds Recalled for Lack of FDA Clearance

    Zeppessis Reprocessing is recalling reprocessed single-use manifolds for Stryker Neptune systems because they lack FDA 510(k) clearance and a validated cleaning protocol.

    Product
    Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2260-2013·2013-09-25

    Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise

    Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.

    Product
    Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2013·2013-09-25

    Cincinnati Sub-Zero Blanketrol III Manuals Recalled for Labeling Error

    Cincinnati Sub-Zero is recalling Blanketrol III manuals because text was incorrectly added back, contradicting the device's approved intended use.

    Product
    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
    Category
    Medical Device
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-2202-2013·2013-09-25

    Sonogage EyeScan A-Scan Biometer Recalled for Lack of FDA Clearance

    Sonogage Inc is recalling 564 EyeScan A-Scan Biometers because the firm lacked FDA registration and 510(k) clearance for the device.

    Product
    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2196-2013·2013-09-25

    Assuramed Recalls DiaScreen Liquid Urine Controls Due to Storage Temperature Issues

    Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.

    Product
    DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2242-2013·2013-09-25

    3M Recalls Scotchcast Cast Padding Due to Water Repellency Issues

    3M is voluntarily recalling specific lots of Scotchcast Wet or Dry Cast Padding because the material does not consistently repel water, which may prolong cast drying times.

    Product
    3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization.
    Category
    Medical Device
    Distribution
    33 states
  • LowFDA (Food)·F-1907-2013·2013-09-25

    Novartis Recalls Benefibre Orange Creme Chewables Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Benefibre Orange Creme Chewables because the lot number and expiration date may be illegible on the packaging.

    Product
    Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: Novartis Consumer Health Canada Inc, Mississauga, ON.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1903-2013·2013-09-25

    Novartis Recalls Benefiber Wild Berry Chewables Due to Illegible Labeling

    Novartis Consumer Health is recalling specific lots of Benefiber Wild Berry Chewables because the lot number and expiration date may be illegible on the outer packaging.

    Product
    Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1061-2013·2013-09-25

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Defective Seals

    Watson Laboratories is recalling 875 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets because defective bottles may have improperly seated tamper-evident seals.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1905-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Benefiber fiber supplement bottles because the lot number and expiration date may be illegible on the outer packaging.

    Product
    Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1906-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling 419,040 units of Benefiber chewable tablets because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1904-2013·2013-09-25

    Novartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling specific lots of Benefiber Orange Creme Chewables because the lot number and expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2255-2013·2013-09-25

    King LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error

    King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.

    Product
    King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach…
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·13V452000·2013-09-23

    GM Recalls 2013-2014 Chevrolet Cruze for Axle Shaft Fracture Risk

    General Motors is recalling 2013-2014 Chevrolet Cruze vehicles with manual transmissions because the right front half shaft may fracture, potentially causing loss of power or unexpected movement.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V450000·2013-09-23

    Audi Recalls 2013-2014 S6 and S7 Models for Fuel Line Leak Risk

    Volkswagen is recalling 2013-2014 Audi S6 and S7 vehicles because a fuel line may leak, posing a fire risk if exposed to an ignition source.

    Product
    AUDI — AUDI S6, S7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V462000·2013-09-23

    Cargo Craft Recalls 2006-2013 Trailers Due to Door Lock Jamming Risk

    Cargo Craft is recalling 2006-2013 cargo trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    CARGO CRAFT — CARGO CRAFT CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V485000·2013-09-20

    New Flyer Recalls 2004-2006 D40I Buses Due to Fire Risk

    New Flyer is recalling 57 D40I transit buses from 2004-2006 because electrical components may conduct electricity and cause a fire.

    Product
    NEW FLYER — NEW FLYER D40I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V460000·2013-09-20

    Coach and Equipment Recalls 2009-2010 Metro-Lite and Phoenix Buses for Fire Risk

    Coach and Equipment is recalling 2009-2010 Metro-Lite and Phoenix buses equipped with optional power doors due to a potential circuit board overheating issue that could cause a vehicle fire.

    Product
    COACH & EQUIPMENT — COACH & EQUIPMENT PHOENIX, METRO-LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V459000·2013-09-20

    New Flyer Recalls 2012 XN40 Buses with Defective Bicycle Racks

    New Flyer is recalling 2012 XN40 transit buses because cracks in certain bicycle racks may cause parts to fall off, creating a road hazard.

    Product
    NEW FLYER — NEW FLYER XN40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V457000·2013-09-19

    North American Bus Industries Recalls Transit Buses Due to Fire Risk

    North American Bus Industries is recalling specific transit buses because a battery equalizer component may conduct electricity and cause a fire.

    Product
    OPTIMA — OPTIMA, NABI, BLUE BIRD OPUS, LFW, CLFW, BRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V412000·2013-09-19

    Honda Recalls 2003-2004 Odyssey and 2003 Acura MDX for Air Bag Defect

    Honda is recalling 2003-2004 Odyssey and 2003 Acura MDX vehicles because electrical noise may cause air bags to deploy unexpectedly, increasing injury risk.

    Product
    ACURA — ACURA, HONDA MDX, ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13751·2013-09-19

    The Land of Nod Recalls Iron Sleigh, Petal, and Picket Bed Frames

    The Land of Nod is recalling specific iron bed frames due to an entrapment hazard for young children. One incident of entrapment was reported without injury.

    Product
    Iron Sleigh, Petal and Picket bed frames
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13289·2013-09-19

    Shimano Recalls Disc Brake Calipers Due to Collision Hazard

    Shimano American is recalling approximately 6,600 disc brake calipers in the U.S. because they can fail, posing a collision hazard. No injuries have been reported.

    Product
    Disc brake calipers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2126-2013·2013-09-18

    Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2125-2013·2013-09-18

    Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2123-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall

    Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2124-2013·2013-09-18

    Siemens Microscan Plus Negative Combo 3 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1010-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Vitamin D Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Vitamin D 50,000 I.U./ML Injectable due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-962-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling compounded sterile injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2181-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination

    FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.

    Product
    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-960-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Compounded Glutamine Injection Solution

    Beacon Hill Medical Pharmacy is recalling compounded glutamine injection solution due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-999-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Sodium Hydroxide Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Sodium Hydroxide 10% Injection due to FDA inspectional findings regarding sterility assurance.

    Product
    SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1012-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Alprostadil 100 mcg/mL injection solution because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-974-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Lipo-Plex Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Lipo-Plex Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2129-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2182-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination

    FDA is recalling Monoject Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.

    Product
    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-984-2013·2013-09-18

    FDA Recalls Naltrexone Injectable Due to Sterility Assurance Concerns

    The FDA is recalling Naltrexone 1 mg/mL and 200 mg/mL injectables compounded by Beacon Hill Medical Pharmacy due to quality control issues affecting sterility assurance.

    Product
    NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2179-2013·2013-09-18

    Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination

    FDA is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-967-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Hydrogen Peroxide Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Hydrogen Peroxide 3% Injectable because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V455000·2013-09-18

    NOV Rolligon Recalls Trailers Due to Missing Suspension Weld

    NOV Rolligon is recalling specific 2011-2012 trailers because a missing weld on the rear suspension could cause the trailer to pull to one side or shift load, increasing crash risk.

    Product
    ROLLIGON — ROLLIGON MT-1060, HT-180, MT-1060-HR, HT-270
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Manganese Sulfate Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Manganese Sulfate 0.1 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.

    Product
    MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-949-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Dextrose PF 50% Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Dextrose PF 50% Injectable because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1005-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls TRI-MIX Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling TRI-MIX injection solutions because FDA inspectional findings raised concerns about sterility assurance and quality control.

    Product
    TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-972-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls L-Tryptophan Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling L-Tryptophan 300 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.

    Product
    L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-989-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Potassium Chloride 2 mEq/mL Injectable because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.

    Product
    POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-973-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Lidocaine Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Lidocaine MDV and Lidocaine PF injectables because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-987-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Parabens Water for Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling all presentations of Parabens Water for Injection because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.

    Product
    PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1032-2013·2013-09-18

    Wellness Pharmacy Recalls Methyl B12 Vials Due to Sterility Concerns

    Wellness Pharmacy is recalling Methyl B12 1 mg/mL single-use vials because laboratory results indicated microbial contamination and the FDA questioned the reliability of the testing.

    Product
    Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1008-2013·2013-09-18

    FDA Recalls Triptropin Plus Injectable Due to Sterility Assurance Concerns

    Beacon Hill Medical Pharmacy is recalling Triptropin Plus Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-998-2013·2013-09-18

    Sodium Bicarbonate Injectable Recalled for Sterility Assurance Concerns

    Beacon Hill Medical Pharmacy is recalling Sodium Bicarbonate PF 8.4% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1002-2013·2013-09-18

    FDA Recalls Testosterone Injectable Due to Sterility Assurance Concerns

    Beacon Hill Medical Pharmacy is recalling Testosterone Hypoallergenic and Testosterone Aqueous injectables due to FDA inspectional findings regarding sterility assurance.

    Product
    TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-995-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Quad Amino Blend Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Quad Amino Blend 150/75/150/75 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.

    Product
    QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1031-2013·2013-09-18

    Wellness Pharmacy Recalls Magnesium Sulfate Vials Due to Sterility Concerns

    Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.

    Product
    Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-976-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Magnesium Chloride Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Chloride Hexahydrate 20% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-954-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Estradiol Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding sterility assurance.

    Product
    ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2127-2013·2013-09-18

    Siemens MicroscanrapID/S panels recalled for antimicrobial misreads

    Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2128-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-957-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Estriol Oil Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Estriol 5 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.

    Product
    ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1879-2013·2013-09-18

    Reaction Nutrition Recalls Immune Support Supplement for Undeclared Colostrum Allergen

    Reaction Nutrition LLC is recalling 600 bottles of Clinical LIVE Immune Support capsules because they contain undeclared colostrum, a dairy allergen.

    Product
    Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V441000·2013-09-18

    Spartan Motors Recalls 2011-2013 Transit Buses for Control Arm Fracture Risk

    Spartan Motors is recalling 75 model year 2011-2013 Transit Bus Chassis Cab vehicles because front suspension control arms may fracture without warning, increasing crash risk.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2186-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water

    The FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.

    Product
    Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-953-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls EDETATE DISODIUM INJECTABLE Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling EDETATE DISODIUM 150 MG/ML INJECTABLE because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.

    Product
    EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-943-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Calcium Chloride Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Calcium Chloride 100 mg/mL Injectable because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide

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