Worldwide Distribution - USA (nationwide) Distribution and to the countries of :   Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, Iceland, India, Iran, Israel, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine, Vietnam, Yemen, Argentina, Brazil, Chile, and Dominican Republic
Prismaflex Control Unit.  Dialyzer, high permeability with or without sealed dialysate system.    Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to  safe default  values unintentionally.
US Distribution to the state of  California, and Internationally to Canada and Sweden
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case.    Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
US Nationwide in the states of AK, AL, AR, AZ, CA, FL, GA, IA, ID, KS, KY, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, including Hawaii and Puerto Rico
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch.
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3    Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
lengths - 30 catheters per box, each catheter is packaged in an individual pouch.    Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
TM, NV, PA, MA, CA, NC, TX, VA, IL, OR, ND, TN,, FL, AZ, ID, OH,, HI, WA, MO, VT and foreign distribution to Canada,  Aruba, Bahamas and Arab Emirates.
Smokehouse Brand Beefy Munchies, Real  flavors of Beef, slow roasted to perfection. Beef Lungs dog treats, Made in the USA.     Ingredient: Beef Lungs    UPC 7 7856585795 7 4 oz.    All packaging configurations:    4 oz. Beefy Munchies / vinyl bag with header card - UPC - 0 78565 85795 7;  8 oz. Beefy Munchies / vinyl bag with header card - UPC - 0 78565 85793 3;  16 oz. Beefy Munchies / vinyl bag with header card -  16 oz. beefy Munchies / vinyl bag with label  6 oz. Beefy Bites / plastic tube with label      Smokehouse Pet Products, Inc.  11850 Sheldon Street  Sun Valley, CA 91352
350 x 4 oz. bags - expansion amount not yet provided
Colorado Department of Agriculture sampled Beefy Munchies at retail and had a positive result for Salmonella
Lot  449294, Use by 10-25-19  Expansion 2-15-18 - includes all lots
LeadCare II Blood Lead Analyzer  Part Numbers: 70-6760, 70-6529-R, 70-6760-P,  70-6760-R.    Intended for in vitro (external) use only.
The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and   70-6760-R.  All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
LeadCare Plus Blood Lead Analyzer  Part Number: 82-0001    Intended for the quantitative measurement of lead in a whole blood sample.
The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
Part Number: 82-0001.  All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.
Product packaging may not be completely sealed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Gordon Choice Asian Sesame Ginger Dressing, Net Contents/Contenido Neto 128 FL OZ; For Distribution Exclusively By Gordon Food Service Wyoming, MI 49509
A blue plastic bag was inadvertently introduced into product stream. During the manufacturing process, the blue plastic bag was torn into many pieces and ended up in the finished product. While many pieces of the blue plastic bag have been recovered, there is no evidence that all pieces are accounted for.
US nationwide distribution, including Puerto Rico.
Radial Artery Catheterization Kit; Model: AK-04220
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Radial Artery Catheterization Kit; Model: AK-04018
Arterial Access Tray, introducer catheter; Model: GU-04020
Radial Artery Catheterization Kit; Model: AK-04020
Radial Artery Catheterization Kit; Model: AK-04020-C
Radial Artery Catheterization Kit; Model: AK-04120
Radial Artery Catheterization Kit; Model: AK-04122
Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020
Worldwide Distribution - US Distribution to the states of :  CA, CO, FL, IL, MN, NV, OK, TX., and to the countries of : Canada, China, Ecuador, England, Greece, Guatemala, Jordan, Lebanon, Mexico, Romania, Russia, South Korea, Taiwan, Japan and  United Arab Emirates.
Alpha Air 6 ENT Microscope    Microscope examination of the human ear, nose, and throat.
The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.
Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
The drill guides were manufactured with the incorrect color anodization.
Package Lot: 989430; Lot Etched on Product: P0284
Dynavox T15 Speech Generating Device ( including Batteries)
The battery is integral to the device.  If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire.  The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells.  This battery may cause the device case to separate a small amount.
TL1405   TL1407   Part Numbers: T15: 750423  Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
Dynavox T10 Speech Generating Device ( including Batteries)
TS1308   TS1411     Part Numbers: T10: 750394   Date Codes are part of the device s unique Serial Number and represent the year and month the device was manufactured.
US Distribution to the states of:  AZ, CA, NC, TX, and VA.
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461    The Oncomine  Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM  Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens.
US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function  OK to All  in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the  OK  function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
Phadia Prime software 12-4101-00  Phadia 250 12-3900-01    Listed software:  EliA dsDNA Well 14-5500-01  EliA U1RNP Well 14-5501-01  EliA Sm Well 14-5502-01  EliA Ro Well 14-5503-01  EliA La Well 14-5504-01  EliA CENP Well 14-5505-01  EliA Scl-70 Well 14-5506-01  EliA Jo-1 Well 14-5507-01  EliA Symphony Well 14-5508-01  EliA RNP70 Well 14-5511-01  EliA GBM Well 14-5514-01  EliA CCP Well 14-5515-01  EliA Celikey IgA Well 14-5517-01  EliA Celikey IgG Well 14-5518-01  EliA Gliadin IgA Well 14-5519-01  EliA Gliadin IgG Well 14-5520-01  EliA Cardiolipin IgA Well 14-5528-01  EliA Cardiolipin IgG Well 14-5529-01  EliA Cardiolipin IgM Well 14-5530-01  EliA B2-Glycoprotein I IgA Well 14-5531-01  EliA B2-Glycoprotein I IgG Well 14-5532-01  EliA B2-Glycoprotein I IgM Well 14-5533-01  EliA PR3S Well 14-5536-01  EliA MPOS Well 14-5537-01  EliA GliadinDP IgA Well 14-5538-01  EliA GliadinDP IgG Well 14-5539-01  EliA RF IgM Well 14-5600-01  EliA RF IgA Well 14-5601-01  EliA SmDP Well 14-5624-01  EliA Scl-70S Well 14-5637-01  EliA anti-TPO Well 14-5641-01  EliA anti-TG Well 14-5642-01  EliA M2 Well 14-5649-01
ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016).    ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01).    ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma.  To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
buPROPion HCl Extended-Release Tablets,   USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03)  and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Failed Dissolution Specifications; during stability testing
buPROPion HCl Extended-Release Tablets,   USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
US Distribution in states of: CA, FL and IN.
Elecsys BRAHMS PCT    Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
Elecsys BRAHMS PCT: 07301715190 Lot number 204084
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System    Product Usage:  The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).
Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)
Uterine Electromyographic Monitor -Monica IF24 Interface System    Product Usage:  The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal monitor. The Monica IF24 CTG Interface Device enables signals collected by the Monica AN24 to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. The device is intended for use by healthcare professionals in a clinical setting.
if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).
Model # - 105-PT-001 ( all units distributed from October 2011 - May 2016)
Fresenius Medical Care Renal Therapies Group, LLC
US Distribution to the states of:  AR, CA, CO, FL, GA, IL, MA, MD, MN, NC, NY, OH, PA, SC, TN, and TX.
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number)    ndicated for acute and chronic dialysis therapy.
When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany.      Distributed internationally to Germany.
CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm    The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube.  Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window.
International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
US Distribution was made to CA.  There was no foreign/military/government distribution.
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies.  Added other contraindications.  Updated cleaning and sterilization instructions.
DS Clip Appliers - Product Numbers  PL808R  DS SINGLE FIRE LAP.APPLIER L 12/310MM  PL802R  DS SINGLE FIRE LAP.APPLIER SM 5/310MM  PL826R  DS SINGLE FIRE LAP.APPLIER M 10/420MM  PL817R  DS SINGLE FIRE LAP.REM.FORC.ML 10/310MM  PL828R  DS SINGLE FIRE LAP.APPLIER L 12/420MM  PL809R  DS SINGLE FIRE LAP.APPLIER XL 12/310MM  PL806R  DS SINGLE FIRE LAP.APPLIER M 10/310MM  PL818R  DS SINGLE FIRE LAP.REM.FORC.L 12/310MM  PL801R  DS SINGLE FIRE LAP.APPLIER S 5/310MM  PL816R  DS SINGLE FIRE LAP.REM.FORC.M 10/310MM  PL807R  DS SINGLE FIRE LAP.APPLIER ML 10/310MM  PL822R  DS SINGLE FIRE LAP.APPLIER SM 5/420MM  PL827R  DS SINGLE FIRE LAP.APPLIER ML 10/420MM
DS Titanium Ligation Clip, used in laparoscopic surgery
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies.  Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors.  The information from this publication was not approved or validated by the firm.
DS Clips - Product Numbers  PL450SU  DS SINGLE FIRE LIG.CLIPS  PL471SU  DS SINGLE FIRE LIG.CLIP L W/LATCH  PL453SU  DS SINGLE FIRE LIG.CLIP SM  PL475SU  DS SINGLE FIRE LIG.CLIP XL W/LATCH  PL459SU  DS SINGLE FIRE LIG.CLIP M  PL462SU  DS SINGLE FIRE LIG.CLIP ML  PL465SU  DS SINGLE FIRE LIG.CLIP ML W/LATCH  PL468SU  DS SINGLE FIRE LIG.CLIP L  (all clips going back 5 years)
Device is software only.  No products are distributed to wholesale dealers, distributers or retailers
Syngo.via.  Medical Device Software. Picture archiving and communications system.
A software functionality in the report sections  Findings Information  and  Summary of Measured Findings  is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Josie's Homestyle #1 Pralines Net Wt. 2 oz (57 g) bag INGREDIENTS: Sugar, Cream, Pecans, Butter, Vanilla, if (Rum) Rum Flavoring. If (Coconut) Coconut. Made By: Josie's Homestyle #1 Pralines, etc. 718 1/2 Filmore St. Kenner, LA 70062 UPC 6 71572 00718 8
During an FDA inspection the firm was notified that the product was mislabeled due to the label indicating that the product contains cream when the firm actually uses evaporated milk and they fail to provide the sub ingredients for butter on the label.
GE Healthcare Centricity PACS-IW, Model Numbers:  (a) 2052831-00X  (b) 2049588-008    Product Usage:  Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more  image series  (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.
Directly distributed to the following states:   AZ  CA  CO  CT  FL  GA  HI  IA  IL  KS  MA  ME  MN  MT  NH  NJ  NV  NY  OK  PA  SC  UT  VT  WA
Coconut Smiles - Retail: International Harvest Brand Organic Go Smile! Dried Coconut Raw, in a 9 oz. poly/plastic bag, UPC: 7 39446 40220 7 NON GMO; Bulk: 25 lb. boxes
24,270 - 9 oz. Bags and 14,620 lbs. Bulk Boxes
To 145 Retail Natural Grocer stores nationwide.  No govt/VA/military/foreign consignees.
Natural Grocers Organic Coconut Smiles, 10 oz. plastic resealable bag, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228  (303) 986-4600
Coconut smiles product tested positive for Salmonella.
Distributed to retail stores in Utah. No foreign/VA/govt/military consignees.
ECLIPSE Kratom Premium Maeng Da, 40 count capsules and 2 oz bottles, Distributed by Tamarack Inc. Cheyenne, WY
Tamarack Inc. is recalling Eclipse Kratom-containing powder products because it may be contaminated with Salmonella.
directly distributed in CA, CO, FL, GA, MD, MI, MN, NY, OH, PA, RI, TX, and WA.
Rad Cat Raw Diet Free-Range Chicken.  Product has the following UPCs:     UPC 851536001036 - 8 oz. tub  UPC 851536001043 - 16 oz. tub  UPC 851536001050 - 24 oz. tub
Rad Cat Raw Diet Free-Range Chicken is recalled because they have the potential to be contaminated with Listeria monocytogenes.
Rad Cat Raw Diet Free-Range Turkey.  Product has the following UPCs:    UPC 851536001005 -   8 oz. tub  UPC 851536001012 - 16 oz. tub  UPC 851536001029 - 24 oz. tub
Rad Cat Raw Diet Free-Range Turkey Recipe is recalled because they have the potential to be contaminated with Listeria monocytogenes.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Device is software.  Customer notification letters recommended that users discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC maps calculated by DynaCAD. ADC maps originating natively from the MRI system should be used as an alternative as these values are unaffected. Firm will provide a v4.0 software update for the affected software versions (v3.4, v3.5) to correct the defect at no charge to the user.
DynaCad software consist of an MR Analysis Server software and the viewer workstation software.  The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules.    Product Usage:  Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.
Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client.  The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD s on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps. If the ADC values are computed on-the-fly by DynaCAD, the ADC values and colors will also display incorrectly if viewed on a remote DynaCAD client.
Product contains undeclared milk and soy oil and lecithin.
AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NY, OH, OR, PA, SC, TX, VA, VT, WI
King Arthur Flour, 100% Organic, Finely Ground, Coconut Flour, UPC 0 71012 10702 5, Distributed by: The King Arthur Flour Co., Inc., Norwich, Vermont 05055  Product of the Philippines and/or Sri Lanka.
Coconut flour tested positive for Salmonella.
Product was shipped to the following states: AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, NC, NH, NJ, NV, NY, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Milos Kitchen Steak HOMESTYLE DOG TREATS Grillers/Steak Grillers Recipe with Angus Steak 10 oz. bag UPC 079100527762, 18 oz. bag UPC 079100518227 & 22 oz. bag, UPC 079100518234, DISTRIBUTED BY: Milo's Kitchen, LLC San Francisco, CA 94111
The firm was notified that the product contains harmful, elevated levels of beef thyroid hormone.
10 oz. bag, Lot Code 7305, Best If Used By 4/26/2019; 18 oz. bag, Lot Code 7143, Best If Used By 11/15/2018 & Lot Code, 7305, Best If Used By 4/26/2019 and 22 oz. bag, Lot Code 7305, Best If Used By 4/26/2019.
Milo's Kitchen home-style dog treats Grilled Burger Bites with Sweet Potato and Bacon 15 oz. bag UPC 079100521265 DISTRIBUTED FOR: Milo's Kitchen, LLC A subsidiary of Del Monte Foods San Francisco, CA 94111
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Distributed for sale in hotels in CO, LA, MN, and TX
diet Pepsi, 12 FL OZ, in aluminum cans packaged in 12 pk paper cartons
Diet Pepsi product is labeled to contain the artificial sweetener Sucralose, but actually contains Aspartame
Wegmans Stores in MA, MD, NJ, NY, PA and VA.
Wegmans Yogurt Raisins, 9 OZ (255g), in a plastic tub, UPC: 0 77890 31832 4,
FRANK & TONY'S NEW YORK STYLE RED ONION SAUCE, 15oz. (420g) glass jar, UPC: 6 00231 21502 2
Product contains undeclared fish (anchovy).
Healthy Nut Factory ORGANIC COCONUT SMILES, Net Wt. 7 oz, UPC: 8 13449 02099 3
Product may be contaminated with Salmonella.
Red Blood Cell, collected from an ineligible donor, was distributed.
Blood products, in which residual WBC count were not performed, were distributed.
W165717004772S (double collection); W165718004408E (double collection)
Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.