Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
Mobile Diagnostic X-Ray System with Digital Panel
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.
AZ  CA  Co  CT  FL  GA  IL  KS  MA  MD  MI  MN  MO  NC  NJ  NV  NY  OH  OR  PA  TX  UT  VA  WA
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.
identifying the allergens as Milk and Treenuts.
Choklad Ljus Milk Chocolate    Net Wt 3.5 OZ;  IKEA  Produced in Spain For: IKEA Food Services, AB, Almhultsgatan 2, SE-21586 Malmo, Sweden.
statement identifying almond and hazelnuts.
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.
statement identifying: Almonds and Hazelnuts.
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.
statement identifying Almonds and Hazelnuts.
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.
. This statement does not declare the almond and hazelnut.
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
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.
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
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
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
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.
US Distribution  : MA ., Internationally to Japan
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.
Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
Product was shipped to the following states: FL, GA, IL, IN, KY, MA, MI, NJ, OH, PA & WI.
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
The firm was notified by their supplier that various cheese products test positive for Listeria monocytogenes.
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
3 cs /15/12 oz packages & 10/12 oz packages
Marketside Grab and Go Col Colby 10.8 oz Set Ups
12,871.36 cases of 11 / 10.8 oz packages
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
23,023.63 cases of 11 / 10.8 oz packages
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
Nationwide through Amazon.com online and direct from firm's website www.xtrahrd.com and www.Zrect.com
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
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).
Domestic: MI, IL, IN, KY, MD, OH, PA, TN, VA, WI, WV    Foreign: None  VA/DOD: None
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.
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;
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.
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
Product sterility is compromised due to breach of sterile barrier
Lot Number beginning with:  12,  13, 14, 15, 16  Expiration Date: From February 2017 through November 2021
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.
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
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 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
VivaCeuticals, Inc. dba Regeneca Worldwide
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.
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
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.
Device Listing Number: D149129  Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
Nationwide with most being sold at retail locations in the Northeastern and Mid-Atlantic States, California, Chicago IL, Portland Oregon and Washington, DC.
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 Electronics North  America Corporation
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
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.
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]
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
Blood and Blood Products for Reprocessing
Blood product, in which donor suitability was not adequately determined, was distributed.
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.
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.
Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
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.
Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018
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.
Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018;  BXHCUD1A, BXHCUF2A, Exp. 01/2019.
Human Sclera, mislabeled with an extended expiration date, was distributed.
Source Plasma units, collected from an ineligible donor, were distributed.
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.
NucliSENS Lysis Buffer, REF 200292  NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Problem with colored eluates for whole blood extractions
Product was distributed to retail distribution companies throughout the United States.
Nestle Butterfinger Peanut Butter Crisp Chocolate Candy Bar in 3-pack SharePack (2.01 oz); and in 6-pack Snack Tray (4.02oz)
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.
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
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.
851 units total for all products (291 units in US)
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.
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.
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
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
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.
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.
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.
The product was marketed without 510(k) clearance.
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
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars;  3 - 3 FL oz.. bars (9 FL ox (266 ml)
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.
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.
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.
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.
Superpotent Drug: An oversized tablet was found in a bottle.
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL
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.
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.
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.
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-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.
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
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.
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
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.
Product was distributed for further manufacturing to customers in MO and TX.
Premark HS Vitamin RDA Premix, Net Wt. 50 lbs., Item No. 136375.
Product manufactured with an ingredient that contains low levels of soy; soy is not declared on product label.
Lot number and Expiration date:  HSRDA-290616-50, 6/29/17
iXL Advanced Performance Matrix, Nutritional Premix, Net Wt. 50 lbs., Item No. 136375.
Product was sold in the following states: IL, OH & PA.
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
424 cases/12/2/8 oz packages + 7/2.8 oz packages
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
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.
Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton,  Rx Only,  Dynax Corp., Burlington, MA. NDC47783-101-01
Worldwide Distribution - US (Nationwide)  Internationally to Australia, Brazil, Canada, Columbia, Cyprus, Japan, Spain
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
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.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Minnesota; Pennsylvania; Arkansas; Kentucky; Colorado; Puerto Rico; New Jersey; Nebraska; Virginia; South Carolina
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, in which donor suitability was not adequately determined, were distributed.
Product was distributed to at least three distributors in the US.
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.
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.
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.
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
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
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.
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
Failed Impurities/Degradation Specifications; Impurity A