Recalling Firm
VivaCeuticals, Inc. dba Regeneca Worldwide
Philips Electronics North America Corporation

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
AZ CA Co CT FL GA IL KS MA MD MI MN MO NC NJ NV NY OH OR PA TX UT VA WA
US Distribution : MA ., Internationally to Japan
Product was shipped to the following states: FL, GA, IL, IN, KY, MA, MI, NJ, OH, PA & WI.
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
Domestic: MI, IL, IN, KY, MD, OH, PA, TN, VA, WI, WV Foreign: None VA/DOD: None
Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
Nationwide with most being sold at retail locations in the Northeastern and Mid-Atlantic States, California, Chicago IL, Portland Oregon and Washington, DC.
Worldwide Distribution - US Nationwide including the countries of: Australia Belgium Canada Denmark Finland France Germany Germany India Italy Netherlands Norway Qatar Singapore South Africa Sweden Switzerland United Kingdom
Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.
Product was distributed to retail distribution companies throughout the United States.
Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia
US and Australia, Thailand, Great Britain, Germany, Japan, Netherlands, France, Taiwan, Canada, South Africa, China, Slovenia, Spain, Italy, Norway, India, Russia, Finland, Czech Republic, Singapore, Denmark, Korea, Ireland, United Arab Emirates, .Belgium, Switzerland and Sweden.
US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
Product was distributed for further manufacturing to customers in MO and TX.
Product was sold in the following states: IL, OH & PA.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Luxembourg, Monaco, Netherlands, Norway, Portugal, Puerto Rico, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela
Worldwide Distribution - US (Nationwide) Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
Minnesota; Pennsylvania; Arkansas; Kentucky; Colorado; Puerto Rico; New Jersey; Nebraska; Virginia; South Carolina
Product was distributed to at least three distributors in the US.
AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada

Product Description
Mobile Diagnostic X-Ray System with Digital Panel
Choklad Not; Milk Chocolate with hazelnut Net Wt 3.5 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
Dark Chocolate bars Choklad Mork Dark Chocolate, Net Wt. 3.5 OZ. AND Chokland Mork Dark Chocolate 70%, Net Wt. 3.5 OZ. Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
Choklad Ljus Milk Chocolate Net Wt 3.5 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
Godis Chokladkrokant Milk chocolate with butterscotch pieces; Net Wt 15.9 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
Choklad Lingon & Blabar Assortment of milk chocolate Squares with lingonberry pieces and dark chocolate squares with bilberry pieces; Net Wt 6.3 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
Godis Chokladran Wafers filled and covered with Milk chocolate; Net Wt 5.9 OZ; IKEA Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
NeoTerramycin 100/100D Type A Medicated Article Net Wt. 50 lbs. (22.7 kg) Phibro Animal Health Corporation Teaneck, NJ 07666
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.
DIETZ & WATSON Pepper Jack Cheese NET WT. 8 OZ. (227G) INGREDIENTS: Cultured Pasteurized Milk, Jalapeno Peppers, Salt, Enzymes. CONTAINS: MILK DISTRIBUTED BY: DIETZ AND WATSON, INC. PHILADELPHIA, PA 19135 UPC 0 31506 79450 6
FINLANDIA SRIRACHA JACK & JALAPENO JACK CHEESE NET WT. 12 OZ. (340g) SRIRACHA JACK INGREDIENTS: PASTEURIZED MILK, CULTURES, SALT, JALAPENOS, CAYENNE GARLIC, CITRUS POWDER, ENZYMES CONTAINS: MILK JALAPENO JACK INGREDIENTS: PASTEURIZED MILK, RED AND GREEN JALAPENO PEPPERS, CULTURES, SALT, ENZYMES, ANNOTTO CONTAINS: MILK, DISTRIBUTED BY FINLANDIA CHEESE INC., PARSIPPANY, NJ 07054 UPC 6 73803 04508 2
Marketside Grab and Go Col Colby 10.8 oz Set Ups
Marketside Grab and Go Swiss 10.8 oz Set Ups
Marketside Grab and Go No Smoke Provolone 10.8 oz Set Ups
Private Selections HARDWOOD SMOKED GOUDA NET WT 8 OZ (226g) DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45202 UPC 0 11110 60861 1
Marketside Grab and Go Colby Jack 10.8 oz Set Ups
GFS Monterey Jack Cheese with Jalapeno Peppers NET WT. 24 OZ (1.lb 8 OZ) INGREDIENTS: PASTEURIZED MILK, JALAPENO PEPPERS, CHEESE CULTURE, SALT AND ENZYMES. CONTAINS: MILK DISTRIBUTED EXCLUSIVELY BY: GORDON FOOD SERVICE GRAND RAPIDS, MI 49548 UPC 0 93901 77758 4
DIETZ & WATSON Pasteurized Process New York State Cheddar Cheese with Jalapeno & Cayenne NET WT. 8 OZ. (227G) INGREDIENTS: Aged Cheddar Cheese, (Milk, Cultures, Salt, Enzymes), Jalapeno Peppers, Red Cayenne Pepper Flakes, Sodium Phosphate, CONTAINS: MILK DISTRIBUTED BY: DIETZ AND WATSON, INC. PHILADELPHIA, PA 19135 UPC 0 31506 79412 4
DELALLO Premium Sliced HOT PEPPER CHEESE NET WT. 8 OZ. (227G) INGREDIENTS: American Cheese, Cultured Pasteurized Milk, Salt, Enzymes, Jalapeno Peppers***Red Bell Peppers***CONTAINS: MILK GEORGE DELALLO CO., INC., JEANNETTE, PA 15644 UPC 0 72368 12462 9
DELALLO Premium Sliced COLBY CHEESE NET WT. 8 OZ. (227G) INGREDIENTS: Cultured Pasteurized Milk, Salt, Enzymes, Annatto Color CONTAINS: MILK GEORGE DELALLO CO., INC., JEANNETTE, PA 15644 UPC 0 72368 12452 0
Marketside Grab and Go Col. Sharp Cheddar 10.8 oz Set Ups
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
Premo Turkey & Garlic Mayo Item # 207455, Net wt. 5.5 oz; Core-Mark Turkey & Garlic Mayo Item # 568207, Net wt. 5.5 oz; Fresh Grab Turkey & Provolone with Garlic Mayo Item # 455956, Net wt. 5.5 oz
Premo Signature Classic Italian, 1/6 oz.
Premo Ham & Provolone Item # 207851, Net Wt 6 oz; Fresh Grab Ham & Provolone Item # 251745, Net Wt 6 oz; Core-Mark Ham & Provolone Item # 568343, Net Wt 6 oz;
Coffee House Italian Flatbread , Item # 226323 net wt. 6 oz.; Fresh Grab Italian Flatbread , Item # 252323 net wt. 6 oz.
Premo Asiago Italian Item # 207919, Net Wt 6 oz; Fresh Grab Asiago Italian Item # 251847, Net Wt 6 oz; Core-Mark Asiago Italian Item # 568377, Net Wt 6 oz;
Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
artisanal cheese VULTO Creamery HANDMADE CHEESE, Walton Umber, NET WT. 4 lbs
artisanal cheese VULTO Creamery HANDMADE CHEESE, Hamden, NET WT. 3.5 lbs
artisanal cheese VULTO Creamery HANDMADE CHEESE, Ouleout, NET WT. 2 lbs
artisanal cheese VULTO Creamery HANDMADE CHEESE, ANDES, NET WT. 12-13 lbs
artisanal cheese VULTO Creamery HANDMADE CHEESE, Blue Blais
artisanal cheese VULTO Creamery HANDMADE CHEESE, Miranda, NET WT. 0.5 lbs,
Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX4O is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX4O does not automatically provide local monitoring or alarming when connected to the Information Center.
Blood and Blood Products for Reprocessing
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Nestle Butterfinger Peanut Butter Crisp Chocolate Candy Bar in 3-pack SharePack (2.01 oz); and in 6-pack Snack Tray (4.02oz)
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-382-60
Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars; 3 - 3 FL oz.. bars (9 FL ox (266 ml)
BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01.
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
Premark HS Vitamin RDA Premix, Net Wt. 50 lbs., Item No. 136375.
iXL Advanced Performance Matrix, Nutritional Premix, Net Wt. 50 lbs., Item No. 136375.
Schlabach Amish Bakery Chocolate Chip Grand-ola Bar NET WT. 2.8 OZ (80g) UPC 0 14757 13000 2 Contains: Wheat, Tree Nuts, Dairy Ingredients: Oats, chocolate chips (sugar,chocolate liquor, cocoa butter, whole milk, lecithin [an emulsifier], salt, vanilla), brown sugar, wheat, corn syrup***walnuts, soda, vanilla flavoring, cinnamon. Original Amish Bakery, LLC DBA 6007 Township road 351 Millersburg, OH 44654 P:330-674-3087
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
Apheresis Red Blood Cells, Leukocytes Reduced
Kwei Chow brand Mustard Bamboo Shoots with chili in oil, net weight 7.40 Oz, sauce in glass jars, shelf stable
Kwei Chow brand Mustard Strip with chili in oil, net weight 7.05 Oz, sauce in glass jars, shelf stable
Kwei Chow brand Prime Spicy Pot Paste, net weight 7.10 Oz, sauce in glass jars, shelf stable
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09

Product Quantity
3 cs /15/12 oz packages & 10/12 oz packages
12,871.36 cases of 11 / 10.8 oz packages
23,023.63 cases of 11 / 10.8 oz packages
851 units total for all products (291 units in US)
424 cases/12/2/8 oz packages + 7/2.8 oz packages

Reason for Recall
When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
identifying the allergens as Milk and Treenuts.
statement identifying almond and hazelnuts.
statement identifying: Almonds and Hazelnuts.
statement identifying Almonds and Hazelnuts.
. This statement does not declare the almond and hazelnut.
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
The firm was notified by their supplier that various cheese products test positive for Listeria monocytogenes.
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
JLM Manufacturing initiated a recall on 02/21/2017 of multiple ready to eat sandwiches containing cheese because of a supplier's recall of cheese due to Listeria monocytogenes.
Product sterility is compromised due to breach of sterile barrier
The firm is recalling all herbal and dietary supplements because they were not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements.
Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
Philips lntelliVue MX4O WLAN Patient Wearable Monitor may not automatically switch to Monitor Mode with audible alarms when association with central monitoring system is unsuccessful [incomplete]
Blood product, in which donor suitability was not adequately determined, was distributed.
eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Human Sclera, mislabeled with an extended expiration date, was distributed.
Source Plasma units, collected from an ineligible donor, were distributed.
Problem with colored eluates for whole blood extractions
Products may contain small rigid plastic pieces, which could result in cuts or lacerations during consumption.
Red Blood Cells, not manufactured according to cGMP regulations, were distributed.
Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.
Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
The product was marketed without 510(k) clearance.
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Firm received two complaints of finding a Haagen-Dazs Vanilla Milk Almond Bar found in Chocolate Dark Chocolate bar package. Nuts are visible on the bar.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Superpotent Drug: An oversized tablet was found in a bottle.
Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.
Product manufactured with an ingredient that contains low levels of soy; soy is not declared on product label.
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Blood products, in which donor suitability was not adequately determined, were distributed.
BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
One of the dent markers from the DX-D600 dropped down from the overhead rail.
Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Failed Impurities/Degradation Specifications; Impurity A

Code Info
Lot Number beginning with: 12, 13, 14, 15, 16 Expiration Date: From February 2017 through November 2021
Lot Number beginning with: 14, 15, 16 *Exclude lots 16J098062 16J098162 16J098262 Expiration Date: From February 2017 through November 2019
Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019
Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
The following product number and Exchange part numbers containing the combination of HW Revision C.01 .01 with SW Revisions B.05 or B.06 of the Philips IntelliVue MX4O Patient Wearable Monitor
Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018
Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.
Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016020950 4/30/18 2015052650 1/31/18 2014082550 6/30/17
Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2013120690 7/31/18 2013071890 10/31/17
Lot number and Expiration date: HSRDA-290616-50, 6/29/17