Recalling Firm
Implant Direct Sybron Manufacturing, LLC
LifeSouth Community Blood Centers Inc - Birmingham Region
Vitamin Cottage Natural Food Markets, Inc.
Oklahoma Blood Institute - Sylvan N Goldman Center
American National Red Cross, Penn Jersey Region
Lifesouth Community Blood Centers - Montgomery Region

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

Distribution Pattern
Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Worldwide Distribution - US Distribution to the state of CA., and to the countries of : United Kingdom, Germany, France, Czech Republic, Belgium, Panama, Bulgaria, Iran, Argentina, Turkey Romania, Colombia, and Saudi Arabia.
Shop Rite and The Fresh Grocer and other retail stores in CT, DE, MD, NJ, NY, and PA.
Korea, Republic Of(South); Virginia; Tennessee
Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
Coborn's, Marketplace, and Cashwise stores in MN, WI, ND, and SD.
Direct customers in Bay Area of CA only.
Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.
distributed in AK, CA, ID, NM, OK, OR, WA
45 retail locations in Washington, Oregon, Idaho, Montana, Wyoming, Utah, Colorado, Arizona, New Mexico, Texas, Missouri . No foreign/VA/Govt/Military consignees.
Nationwide to AZ, CA, CO, FL, ID, LA, Ml, MN, MO, NM, NV, OR, TX, UT, WA, WY. No foreign/VA/govt/military consignees.
distributed in AR, AZ, CA, CO, HI, IA, ID, KS, MA, MN, NE, NM, NV, OR, UT, WA, and Guam. International countries including Canada, China, Taiwan.
In the United States to Sams Club and BJs and in Canada to Sobeys and Loblaws. 2301 physical cases (1 case = 1 consumer purchase unit), sent to 4 retailers at 39 locations. Shipments were typically 1 3 pallets with one customer receiving 10 pallets; a pallet contains 39 consumer units. Retailer Number of Units (pallets) Locations Retailer Type Sams 2145 units (55 pallets) US (36 stores/ distribution centers) BJs 39 units (1 pallet) US (1 store/distribution center) Sobeys 39 units (1 pallet) CANADA (1 distribution center) Loblaws 78 units (2 pallets) CANADA (1 distribution centers)
Texas; Arkansas; New York; New Jersey; Oklahoma; Georgia

Product Description
roxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10. 32,2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.
IVEA Product Part Number 16100 Model 500A
Blood and Blood Products for Reprocessing
Dr. Jekyll 30 Watermelon; Dr. Jekyll Watermelon V2 domestic
Hyde V2 Watermelon; Mr. Hyde V2 Watermelon International 30; Mr. Hyde V2 Watermelon Domestic 60
Dr. Jekyll V2 Mango Passion Fruit Domestic 30; Dr. Jekyll Mango Passion Fruit V2 domestic
Mr. Hyde 60 Blue Razz; Hyde V2 Blue Razz; Mr. Hyde V2 international Blue Razz sample pack; Mr. Hyde Domestic V2 Blue Razz sample packs
Mr. Hyde Green Apple domestic sample pack
Dr. Jekyll V2 Orange Burst Domestic 30; Dr. Jekyll Orange Burst domestic sample packs
Mr. Hyde Fruit Punch Canada; Mr. Hyde V2 Fruit Punch domestic
Dr. Jekyll V2 international Blue Razz sample packs, Dr. Jekyll Blue Razz V2 domestic
Mr. Hyde Mango Passion Fruit sample packs; Hyde V2 Mango Passion Fruit
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
Shoprite Real Semi-Sweet Chocolate Chips, Net Wt. 24 oz., UPC 41190-02668 best by dates 4-11-2019 and 4-12-2019.
Apheresis Red Blood Cells, Leukocytes Reduced
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Garden of Life, Baby Organic Liquid probiotic formula, 56 ml (1.9 fl oz)
Coborn's/Cash Wise American Rye Bread - UPC 7-33147-20150 Net Wt. 16 oz (1.0 lb) (454 kg) Sell by 9/7/2017
Coborn's/Cash Wise Caraway Rye Bread - UPC 7-33147-20155-8 Net Wt. 16 oz (1.0 lb) (454 g) Sell by 9/6/2017
Panang Curry included in the Beef Panang Curry Dinner, 3.5 oz. 8oz plastic deli container bearing the name Curry Paste. Ingredients: Shallots, Ginger, Garlic, Peanuts, Sugar, Tomato Paste, Fish Sauce(Anchovies, water, salt), Serrano Chili, Tumeric, Galangal, Lemon grass Cumin, Coriander, Kefir Lime Leaf, Shrimp Powder, Contains: Fish Crustaceans, Shellfish Keep Refrigerated
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon One Swan Drive Smyrna, TN 37167, NDC 0869066738, UPC 308690667382; c) GoodSense, Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, NDC 50804-667-38, UPC 846036007374; d) Leader, Distributed By: Cardinal Health, Dublin, Ohio, 43017, NDC 3720511038, UPC 096295382433; e) Signature Care, Distributed By: Better Living Brands, LLC. P.O. Box 99, Pleasanton, CA 94566-0009, NDC 21130-667-38, UPC 321130779155; f) Discount Drug Mart Food Fair, Distributed By: Drug Mart-Food Fair Medina, Ohio 44256, NDC 5394301077, UPC 093351100383; g) Sunmark, Distributed By McKesson One Post Street San Francisco, CA 94104, NDC 4934869649, UPC 010939112330, h) Major, Distributed By: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA, NDC 0904630477, UPC 309046304777
Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, NDC 4125038038, UPC 708820824294, c) Life Brand, Manufactured for: Shoppers Drug Mark/Pharmaprix Toronto, UPC 057800856405
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Natural Grocers Organic Deglet Noor Dates, Target weight is 0.60 - 0.70 lb random weight package, Zip lock plastic bag.
KIND Dark Chocolate Nuts and Sea Salt Bar-containing 12 /1.4 oz (40 g) bars Box :16.08 oz (480 g) per pack. Box UPC: 02652 17751
Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules. UPC 0-26341-12900-2
Simplot Traditional Tater Gem. Net Wt. 30 lb. (13.6 kg), foodservice corrugated case, 6/5 lbs. clear poly bags per case. UPC = 100 71179 00418 9.
Pampers Sensitive Baby Wipes Mega Box. Consumer unit is a printed corrugate case (13x) containing four 56-count pop-top packs with nine 64-count resealable refill packs.
LIFECODES ThromboType 1 Kit, Product No. 303479, UDI No. 10888234500261
Apheresis Platelets, Leukocytes Reduced, Irradiated
***NEW YORK DELI tempeh sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
***SMOKED TEMPEH tempeh sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
***SOUTHERN BBQ tofu sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
***TOFUSTRAMI tofu sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
(1) Ricker Hill Orchards Apple Cider packaged in plastic Half Gallon UV Treated (64 fl. oz.) Jugs UPC 7461380009 (2) Northland Apples Sweet Maine Cider, 12 oz plastic bottle UPC 7461360009

Product Quantity
230 cases (9/cs Half-Gallon) and 62 cases (24/cs12 oz bottles

Reason for Recall
Deviations: Firm failed to control impurity for color change at the API stage. 10/0
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Potential for intermittent lighting (flickering) during use.
Blood product, which did not meet acceptable product specifications, was distributed.
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Blood products, for which donor screening was performed incorrectly, were distributed.
Product contains the unapproved ingredient, picamilon.
Platelet products, for which the WBC count quality control was not performed and labeled as leukoreduced, were distributed.
The high control for the kit is recovering low and may be out of range for assigned values.
Cargill Cocoa & Chocolate is recalling Shoprite Real Semi-Sweet Chocolate Chips due to undeclared milk.
Blood products, which did not meet the acceptable product specifications, was distributed.
There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
The device had an incorrect printed calibration value on the calibration certificate.
Blood product, collected from an ineligible donor, was distributed.
The product may pose a choking hazard to newborns due to the thickness of the liquid.
Coborn's Inc is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy, and egg) as a result of an update to the ingredient profile from the manufacturer of the base.
While reviewing the allergen listings for our products and cross referencing against the updated spec sheet from the manufacturer of the bread base, it was discovered that the allergen statement had been updated from only wheat to wheat, milk, egg and soy.
Panang Curry included in the Beef Panang Curry Dinner does not list peanuts as an allergen, although peanuts are listed as an ingredient.
pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Platelet product, for which quality control testing did not meet specifications, was distributed.
The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
Country Harvest brand Black Thunder Bean Soup is recalled because the ingredients statement declared Dairy Whey but did not declare milk.
Country Harvest brand Lentil Barley Soup is recalled because the ingredients statement declared Dairy Whey but did not declare milk.
Recalling Natural Grocers brand Organic Deglet Dates because it may contain undeclared coconut
Outer box fails to declare the allergen walnuts, the individual bar is properly labeled
Misbranded red blood cell product was distributed.
Simplot Traditional Tater Gem, foodservice case (6/5 lbs. bags), is recalled because customer reported that small pieces of rigid plastic were embedded in some tater gems.
Apheresis product, in which platelet yield did not meet specifications, was distributed.
On Sept 6, 2017 the Procter & Gamble Distributing LLC as part of an investigation, determined that approximately 3 minutes of product produced on August 25, 2017 was released that may have been contaminated with warehouse floor debris.
LIFECODES ThromboType 1 Kit, with the potential to generate a failed assay or sample mistype, was distributed.
Plateletpheresis products, not meeting established specifications, were distributed.
Sandwiches are recalled due to undeclared wheat.
Product contains patulin at levels higher than the FDA established limit of 50ppb
Blood products whose relevant transfusion-transmitted infection testing was performed incorrectly, were distributed.
Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
Apheresis product, for which the quality control testing for pH did not meet specifications, was distributed.

Code Info
Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion chamber ser. #SN002096; Intrabeam ser. #6402101042, Ion chamber ser. #SN002265; Intrabeam ser. #6402101029, Ion chamber ser. #SN002270; Intrabeam ser. #6402101034, Ion chamber ser. #SN002302; Intrabeam ser. #6402101105, Ion chamber ser. #SN002651; and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684.
Lot code 198-17 packed on date is on the front label beneath the Net Weight.
Best Before Date of 12/20/2017 (Lot Code BK16264A1) and Best Before Date of 2/3/2018 (Lot Code BK16308A1)
DAYCODE: 420AUG071703. Breakdown of the code: 420 = Moses Lake, WA manufacturing facility. AUG = August. 07 = 7th day. 17 = year. 03 = line number.
P&G Brand Code: 80287807 Retail UPC: 37000970651 Product Lot Codes 7237184300
Expiration dates or best-by dates: 9/17 and 9/24.
Expiration dates or best-by dates: 9/17 and 09/24.
Expiration dates or best-by dates: 09/17 and 9/24