Deferoxamine 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.
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Implant Direct Sybron Manufacturing, LLC
Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile  Dental Implant component.
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.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, which did not meet acceptable product specifications, was distributed.
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
IVEA Product Part Number 16100 Model 500A
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 and Blood Products for Reprocessing
Blood products, for which donor screening was performed incorrectly, were distributed.
Dr. Jekyll 30 Watermelon; Dr. Jekyll Watermelon V2 domestic
Product contains the unapproved ingredient, picamilon.
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
Platelet products, for which the WBC count quality control was not performed and labeled as leukoreduced,  were distributed.
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.
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.
The high control for the kit is recovering low and may be out of range for assigned values.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Shop Rite and The Fresh Grocer and other retail stores in CT, DE, MD, NJ, NY, and PA.
Shoprite Real Semi-Sweet Chocolate Chips, Net Wt. 24 oz., UPC 41190-02668 best by dates 4-11-2019 and 4-12-2019.
Cargill Cocoa & Chocolate is recalling Shoprite Real Semi-Sweet Chocolate Chips due to undeclared milk.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, which did not meet the acceptable product specifications, was distributed.
Korea, Republic Of(South); Virginia; Tennessee
Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
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
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.
Electric Wheelchair bases:  a) C300   b) C350   c) C400   d) C500
Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
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
The device had an incorrect printed calibration value on the calibration certificate.
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.
Blood product, collected from an ineligible donor,  was distributed.
Garden of Life, Baby Organic Liquid probiotic formula, 56 ml (1.9 fl oz)
The product may pose a choking hazard to newborns due to the thickness of the liquid.
Coborn's, Marketplace, and Cashwise stores in MN, WI, ND, and SD.
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 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.
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
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.
Direct customers in Bay Area of CA only.
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
Panang Curry included in the Beef Panang Curry Dinner does not list peanuts as an allergen, although peanuts are listed as an ingredient.
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.
pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)
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
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
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
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
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
Platelet product, for which quality control testing did not meet specifications, was distributed.
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
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.
distributed in AK, CA, ID, NM, OK, OR, WA
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.
Vitamin Cottage Natural Food Markets, Inc.
45 retail locations in Washington, Oregon, Idaho, Montana, Wyoming, Utah, Colorado, Arizona, New Mexico, Texas, Missouri .  No foreign/VA/Govt/Military consignees.
Natural Grocers Organic Deglet Noor Dates, Target weight is 0.60 - 0.70 lb random weight package, Zip lock plastic bag.
Recalling Natural Grocers brand Organic Deglet Dates because it may contain undeclared coconut
Lot code 198-17 packed on date is on the front label beneath the Net Weight.
Outer box fails to declare the allergen walnuts, the individual bar is properly labeled
Best Before Date of 12/20/2017 (Lot Code BK16264A1) and Best Before Date of 2/3/2018 (Lot Code BK16308A1)
Misbranded red blood cell product was distributed.
Nationwide to AZ, CA, CO, FL, ID, LA, Ml, MN, MO, NM, NV, OR, TX, UT, WA, WY.  No foreign/VA/govt/military consignees.
Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Supplement, 100 Softgel Capsules.  UPC 0-26341-12900-2
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.
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.
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.
DAYCODE:  420AUG071703.    Breakdown of the code:  420 = Moses Lake, WA manufacturing facility.   AUG = August.   07 = 7th day.   17 = year.   03 = line number.
Apheresis product, in which platelet yield did not meet specifications, was distributed.
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.
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.
P&G Brand Code: 80287807  Retail UPC: 37000970651  Product Lot Codes 7237184300
LIFECODES ThromboType 1 Kit, Product No. 303479, UDI No. 10888234500261
LIFECODES ThromboType 1 Kit, with the potential to generate a failed assay or sample mistype, was distributed.
Oklahoma Blood Institute - Sylvan N Goldman Center
Texas; Arkansas; New York; New Jersey; Oklahoma; Georgia
Apheresis Platelets, Leukocytes Reduced, Irradiated
Plateletpheresis products, not meeting established specifications, were distributed.
***NEW YORK DELI tempeh sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
Sandwiches are recalled due to undeclared wheat.
Expiration dates or best-by dates: 9/17 and 9/24.
***SMOKED TEMPEH tempeh sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
Expiration dates or best-by dates: 9/17 and 09/24.
***SOUTHERN BBQ tofu sandwich***plum bistro 2go***Sold by Quickie Stores Inc. 1324 M.L.K. Jr Way, Tacoma, WA 98405***.
Expiration dates or best-by dates: 09/17 and 9/24
***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
230 cases (9/cs Half-Gallon) and 62 cases (24/cs12 oz bottles
Product contains patulin at levels higher than the FDA established limit of 50ppb
American National Red Cross, Penn Jersey Region
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.
Lifesouth Community Blood Centers - Montgomery Region
Apheresis product, for which the quality control testing for pH did not meet specifications, was distributed.