Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
ASK Naturally Creative;   3 Bean Medley Salad;  Net Wt. 10 lb. or Net Wt. 4 LB.
10 lb. tubs: 560 lbs; 28 cases, 2-10lb tubs/case
Product may be contaminated with Listeria monocytogenes.
Wegman's Five Bean Salad;  Net wt. 10 LB.
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79),  Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
42,776 unit dose cups and 17,403 bottles
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
Hydrocodone Bitartrate and Acetaminophen Oral Solution,  7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
32,027 bottles and 16,310 unit dose cups
Domestic: CA, CO, CT, FL, IL, KY, LA, MA, MD, ME, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TX, UT; VA, WA, WI, & WY; Foreign: CHN & COL.
Balanced Guru Antioxidant Masque, Organic Spiced Up Berries Antioxidant Facial Masque. Sold as 4 oz. and 1 oz..
Balanced Guru Moisturizing Masque, Organic Aloe, Lotus & Chamomile. Sold as 8 oz., 4 oz., and 1 oz..
Balanced Guru Astringent Masque, Organic Citrus and Kelp Facial Masque. Sold as 4 oz. and 1 oz. m
U.S. distribution to the following; nationwide including Puerto Rico.
Stags Leap Winery Collection  Basket #752
Tis The Season gift basket, Item No. 1084804
Cakebread Cellars Napa Valley Duet  Basket #396
Vintners Path Merlot Seasons Greetings  Basket #724
The Ultimate Wine and Champagne Collection  Basket #399
Bodega de San Antonio Sangria Traditional  Basket #298
Grgich Hills Napa Valley Selection Basket #713
The Executive with Houdini Blue Cheese Twists, 7 ounces COM 659  SKU# 54002-3, SKU#54087-0
Napa & Sonoma Valley Exclusive  Basket #141
Metal Basket with Handles with Houdini Blue Cheese Twists, 7 ounces COM 659, SKU# 54316-1
Vintners Path Cabernet Seasons Greetings  Basket #763
Sauvignon Blanc and Cabernet Collection  Basket #446
Houdini Napa Valley Collection  Basket #766
Sweets For The Season gift basket, Item No. 1081594
Alfasi Chardonnay Kosher Selection  Basket #847
Wooden Centerpiece gift basket, Item No. 1080571
Houdini Fabric gift basket, Item No. 1072552
Vintners Path Chardonnay Seasons Greetings  Basket #795
Metal Basket with Leather Handles  SKU #54506-6
California Cabernet and Chardonnay Gift  Basket #361
Alfasi Cabernet Kosher Selection  Basket #810
Woven Lacquer Treat Basket with Blue Cheese Savory twist item, SKU# 55263-7,
Hot Cocoa, NOT FOR RETAIL SALE, Prod: 28OCT2016, BB: 28JUN2017, Net Weight: 907 g (2.0 lb), Best Before: 28JUN2017
Possible contamination of product with Salmonella due to incorporation of powdered milk and powdered buttermilk .
Lot Code: AR07047EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 AL 07 ;   Lot Code: AR08047EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 AL 08 ;   Lot Code: AR27097EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 SE 27 ;   Lot Code: AR29067EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 JN 29 ;     UPC: 6 44209 02223 6
50423 Madison Hot Cocoa WIP; Production date 11/30/16
NATIONWIDE US  ARGENTINA      AUSTRALIA  AUSTRIA  BRAZIL  CANADA  CHILE  CHINA  COSTA RICA  ECUADOR  GREECE  INDIA  ITALY  JAPAN  KOREA, THE REP OF (SOUTH)  MALAYSIA  MEXICO  NETHERLANDS  PANAMA  POLAND  SINGAPORE  THAILAND
Vanguard Total Knee System  Vanguard Open Box Femoral Components    Item Number: 183100  Description: VNGD PS OPEN INTL FEM RT 55  Item Number: 183102  Description: VNGD PS OPEN INTL FEM-RT 57.5  Item Number: 183104  Description: VNGD PS OPEN INTL FEM RT 60  Item Number: 183106  Description: VAN PS OPEN INTL FEM-RT 62.5  Item Number: 183108  Description: VAN PS OPEN INTL FEM-RT 65  Item Number: 183110  Description: VAN PS OPEN INTL FEM-RT 67.5  Item Number: 183112  Description: VAN PS OPEN INTL FEM-RT 70  Item Number: 183113  Description: VAN PS OPEN INTL FEM-RT 72.5  Item Number: 183120  Description: VAN PS OPEN INTL FEM-LT 55  Item Number: 183122  Description: VAN PS OPEN INTL FEM-LT 57.5  Item Number: 183124  Description: VAN PS OPEN INTL FEM-LT 60  Item Number: 183126  Description: VAN PS OPEN INTL FEM-LT 62.5  Item Number: 183128  Description: VAN PS OPEN INTL FEM-LT 65  Item Number: 183130  Description: VAN PS OPEN INTL FEM-LT 67.5  Item Number: 183132  Description: VAN PS OPEN INTL FEM-LT 70  Item Number: 183133  Description: VAN PS OPEN INTL FEM-LT 72.5
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left).  Risk delay in surgery.
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
Organ preservation fluid recalled due to potential for bacterial contamination.
Batch / Lot Number:  PBR-0060-392, Reference Number:  SPS1_1 LITER, Manufacturer Date:  06/22/2016, Expiration Date: 06/22/2018 ;     Batch / Lot Number:  PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date:  07/13/2016, Expiration Date:  07/13/2018    Batch / Lot Number:  PBR-0074-337    Batch / Lot Number:  PBR-0060-386
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Xambo, 80 boxes of bulk capsules.  Each containing 12,053 capsules in each box.
West Coast Laboratories is recalling Xambo and Devagrass because there may be presence of 1,3-dimethylamylamine (DMAA).
Upstate New York Transplant Services, Inc.
Blood product, did not meet the acceptable product specifications for release, was distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Chocolate Premium Chocolate Treats  Vanilla Caramels packaged under  the following labels:  (1) Weigel's Mountain Valley Premium Chocolate Treats Milk Chocolate   Vanilla Caramels, 2.75 oz (78g) Tube snack Bag  UPC Code: 024354705039;  (2) Royal Farms Market Place Premium Chocolate Treats Milk Chocolate Vanilla Caramels  2.75 oz (78g) Tube snack Bag  UPC Code:  483743202045
AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, NE, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY
Signature SELECT Vanilla Ice Cream & White Cake ICE CREAM CAKE , NET WT 4 LB 13 OZ, KEEP FROZEN, UPC 021130 114641,  Product Code 06620 ---
The product may contain undeclared walnuts from intermediate layer cake supplier.
Retail: Best By JUN-26-2017, JUL-18-17, AUG-01-17 (Best By date code found on side of each individual unit package); -- Product Code 06620: Julian Dates 14076273, 14076295, 14076309
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy strawberries & cream ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 49800 04776 1 (retail), Product Code 04776 --- Rich Products Corp., Buffalo, NY 14213
Retail: Best By JUN-27-17, JUL-15-17, JUL-23-17, JUL-28-17, AUG-27-17 (Best By date code found on side of each individual unit package); -- Product Code 04776: Julian Dates 14076274, 14076292, 14076300, 14076305, 14076335.
RICH'S 1/4 Sheet White Cake with Vanilla Ice Cream Cake, KEEP FROZEN, UNIT NET WT: 60 OZ (3 LB 12 OZ), COUNT: 4 x 1/4 SHEET CAKES, NET CASE WT: 15 LB, UPC 049800 290013 (retail), Product Code 29001 --- RICH PRODUCTS CORP BUFFALO, NY 14213
Retail: Best By OCT-20-17, NOV-01-17 (Best By date code found on side of individual unit package); Product Code 29001: Julian Dates 14076294, 14076306.
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy vanilla ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 49800 62878 6 (retail), Product Code 62878, and UPC 0 49800 02453 3 (retail), Product Code 02453 --- Rich Products Corp., Buffalo, NY 14213 ,1/4 SHEET VANILLA ICE CREAM CAKE WITH WHITE CAKE LAYERED ICE CREAM CAKE, NET WT 18 LB, 4 UNITS/4 lb 8 oz, Product Code 00180
Retail UPC 049800 628786: Best By JUL-29-17; Product Code 62878: Julian Date 14076306; -- Retail UPC 049800 024533: Best By Dates JUN-25-17, JUL-23-17, JUL-29-17 (Best By date code found on side of each individual unit package); Product Code 02453: Julian Date 14076300, Product Code 00180: Julian Dates 14076272, 14076306
Product was distributed to the following states: IL, IN, KY, MI & OH.
Mikesell's Nacho Cheese FLAVORED TORTILLA CHIPS 2.25 OZ (64g) bag UPC 0 71104 00554 3
The firm was notified by their contract manufacturer that they received ingredients that may be contaminated with Salmonella.
Sell by dates: February 0217 and February 1617
Nationwide.  Foreign:  Belgium  Germany  France  Netherlands
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Orthopedic Salvage System (OSS) 9cm  prosthesis, knee, femorotibial, constrained, cemented, metal/polymer  Knee System Tibial Bodies
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia.  The mislabeling could have the potential risks:  A delay in surgery less than 30 minutes.  Patient undergoes a revision with increased risk of infection.
Apheresis product, collected from a donor who was allowed to donate without a current physical, was distributed.
MEVION S250-Proton Radiation Therapy    Product Usage:  Proton Radiation Therapy
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
Blood products, collected from an ineligible donor, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products,  in which donor suitability was not adequately determined, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products, collected from an unsuitable donor due to a donor screening deviation, were distributed.
Nationwide in USA, ** Internationally- Canada, Curacao
Roland MANZANILLA OLIVES STUFFED WITH ANCHOVIES, DR. WT. 3 OZ. (85g), UPC Code: 41224714021 and Case UPC Code: 10041224714028, Item # 71402, PRODUCT OF SPAIN
Product quality issue.  Through sampling, FDA revealed the presence of non-pathogenic Gram Positive Rods (microorganisms).
Lot No. 95   Production Codes: P1201 Expiration Date: December 1, 2018; and P1130 Expiration Date:  November 30, 2018
Implant Direct Sybron Manufacturing, LLC
U.S. distribution to the following; NM, TX, CA, OR, OH, ME.    Foreign distribution to the following; Netherlands.
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
In response to a consumer complaint, Investigation by the manufacturer determined that a partial black rat was found in the product.
Lot Code: I5EG162A ; Best By Date: Dec 2018
Blood products, which did not meet acceptable product specifications, were distributed.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
VITROS Na+ Slides, (UPN 10758750004812)    For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
659,957 Total Units (249,570 units domestically & 410,387 units internationally)
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU.  If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
Generation (GEN): 1 through 6, 30 through 40, 44 through 49  Expiry Dates: 01-JAN-2017 through 01-JUN-2018
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ  08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Failed Dissolution Specifications; 18 month stability time point
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Worldwide Distribution - US Nationwide and the countries of  Denmark, Brazil, Croatia and Germany
1379 kits (190 kits in U.S.A and 1189 Kits internationally) in total
Lot Numbers: 1) 0336 - Expiration date 2017-01-31  2) 0337 - Expiration date 2017-02-28  3) 0338 - Expiration date 2017-05-31
Lot Numbers: 1) D01196 - Expiration date 2016-12-31  2) D0120 - Expiration date 2017-03-31
Whole Foods Market Northeast Regional Office
Whole Foods Markets Lobster Bisque Distributed by: Whole Foods Market, Englewood Cliffs, NJ 07652  UPC: 8-80632-00100
Back label of Lobster Bisque product was mislabeled as Butternut Squash Soup (which contains fewer allergens [only milk] than the Lobster Bisque [milk, shellfish, wheat])
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Intact Disposable Wands (part of the Intact System)  777-110: 5 Pack 10mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
Intact Disposable Wands (part of the Intact System)  777-120: 5 Pack 20mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  900-120: 5 Pack 20mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  777-115BT: 5 Pack 15mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  777-120BT: 5 Pack 20mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  777-112BT: 5 Pack 12mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  777-112: 5 Pack 12mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  900-115: 5 Pack 15mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  777-115: 5 Pack 15mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  900-130: 5 Pack 30mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System)  900-112: 5 Pack 12mm Disposable    Product Usage:  The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Blood product, with a low pH, was distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Distributed throughout the United States
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
The product is being recalled due to incidence and reports of the product breaking during surgery.
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
Product contains undeclared hazelnut (allergen)
All codes where hazelnut and/or tree nuts are not declared on the label
Kings Pastry Chocolate Bar Cake, 1050 g. Frozen  Product Code: 10135  UPC: 685961101357
PerkinElmer Life and Analytical Sciences, Wallac, OY
MA, SC, TX, AL  OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010    Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
24 instruments and 3 spare disk remover modules
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
Spare Disk Remover Module; Product Number: 61001820    Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
The product was distributed in the US as well as the following foreign countries: Guam and Puerto Rico, Israel, Kuwait, Trinidad and Tobago
Nepro Vanilla High Protein , 8oz metal can
The firm expanded recall to include additional batches.  Product recalled because of off odor and taste due to microbial contamination.
Lot Number 57648RA00  Expiration Date                1Jan1017
Lot Number 57420RA00  Expiration Date                1Oct 2016
Promote with Fiber Vanilla, 8oz metal can
Lot Number 57643RA00/01/02    Expiration Date                 1Oct 2016
Lot Number 57447RA00  Expiration Date                1Oct2016
Lot Number  59879RA00  Expiration Date                1Dec2016
Lot Number 57648RA11  Expiration Date                1Jan 2017
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories    Product Usage:  Intended for primary and revision joint replacement of the radial head.
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
U.S. distribution to the following; CA, VA, AZ, MN, TX, LA, NC, NH, NY, IL, NJ, MI, AK, ND, WA, ME, FL, OK, MA, CO, TN, MD, RI    Foreign distribution to the following; Japan, Philippines, Bermuda.
The Honest Co.  Organic Baby Powder  Net Wt. 4.0 oz. (113 g)  UPC Code: 817810014529
The Honest Co.  Diapering Essentials  UPC Code: 0817810027185    Containing Organic Baby Powder  Net Wt. 4.0 oz. (113 g)
Blood products, identified as unsuitable due to a donor screening deviation, were distributed.
Blood product, in which donor suitability was not adequately determined, was distributed.
Snacking Favorites Organic Veggies with Organic Ranch Dip.    16.25 oz. plastic tray (1.02 lb.)                  UPC barcode: 71651901471 - this is the incorrect barcode that is on the bottom of recalled product.  Correct UPC: 716519014765    Incorrect Allergen Statement: Egg. Milk  Correct Allergen Statement, Egg, Milk, Soy and Mustard.
Mann Packing was notified by a customer that the incorrect bottom label is on their Organic Veggie Tray with Best By date of January 14, 2017 and does not declare the allergens of egg, milk, soy and mustard.
Best if Used by: January 14, 2017;  Lot Serial # 3658366
US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.
Northern California Community Blood Bank
Platelet product, for which QC was unacceptable, was distributed.
Blood product, collected from a donor for whom eligibility was incorrectly determined, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Platelet products, for which WBC quality control was not performed, were distributed.
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd.  Halol-Baroda Highway, Halol-389 350 Gujarat, India.
Hemp & Grain Co., Organic Pea Protein 80%, Net Weight 44.1 lbs. Paper bags, 36 paper bags/pallet.
Del Dee Foods, Inc.withdrew Lot# PP33116-0-D after receiving a report of salmonella found in two sample tests taken from product in the above lot before it reached the consumer.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of :    Algeria  India  Poland  Armenia  Indonesia  Portugal  Australia  Iran  Austria  Iraq  Qatar  Bangladesh  Ireland  Republic of Montenegro  Barbados  Israel  Republic of Serbia  Belarus  Italy  Romania  Belgium  Jamaica  Russian Federation  Bosnia and Herzegovina  Japan  Saudi Arabia  Botswana  Jordan  Singapore  Bulgaria  Kazakhstan  Slovakia  Cambodia  Kenya  South Africa  Canada  Kuwait  South Korea  Canary Islands  Latvia  Spain  Cayman Islands  Lebanon  Sri Lanka  China  Libya  Sweden  Croatia  Lithuania  Switzerland  Cyprus  Macau  Syria
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal.  All Catalog Numbers.    Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism.       Strata Valve Magnet Reverse Polarity (Excludes StrataMR).    Catalog No.     27739  27740  27786  27787  27788  27789  27794  27812  27814  27815  27816  27817  27818  27820  27821  27822  27823  27824  27825  27827  27828  27830  27831  27832  27848  27864  27867  27868  27888  27903  27922  27823  27924  23042  27925  27926  27927  27932  27933  42335  42355  42365  42836  42856  42866  44420  44421  44430  44465  46070  46075  46080  46085  46635  46655  46665  46836  46856  46866  46871  46876  46881  46886  92355  92365  92856  92866  96655  96665
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.
Mammomat Inspiration full, field digital,system,x-ray,mammographic    Product Usage:  The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Distributed throughout the United States.
Syngo.plaza, picture archiving and communications system.
Software update for improvements and to resolve several issues
Los Chileros, Basil Pesto, Net Wt. 6 oz. (170g).  plastic shell container. Keep Refrigerated
Blood Centers of the Pacific - Irwin Center
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, for which a unit received inadequate additive solution, was distributed.
Distributed to a sole distributor in NC.
RENOVIX Guided Healing Collagen Membrane    Intended for use in oral surgical procedures.
Lifesouth Community Blood Centers - Montgomery Region
Plateletpheresis product that did not meet specifications, was distributed.