Recalling Firm
Aldon Food Corp. dba Don's Salads & Don's Food Products
Fagron Compounding Services LLC dba Fagron Sterile Services

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

Distribution Pattern
AL, AZ, CA, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, France, Germany, India, Italy, Japan, Korea, Luxembourg, Singapore, Spain, Switzerland, The Netherlands and United Kingdom
AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
US Distribution to the states of : IN, MI, IA
Product was sent to the following states: CA, FL, GA, IL, KS, MD, MI, NC, NJ, NY, TX, VA & WA.
Distributed to consumers who purchased the product in the recalling firm's retail stores in the following US states: IA, IL, IN, MO, and WI.
US: AZ, CA, CO,, FL, IA, ID, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, PA SC, SC, TX, WI, WY. OUS: ISRAEL
Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
All product was shipped to Canada. Monfitello, Inc. 2700 Jean-Baptiste-Deschamps Machine, Quebec H8T1E1 Canada
Worldwide Distribution to the country : UK
RI, ME, NY, CT, PA, VA, NJ, MA, NC, WI, NH
US. AR, AZ, CO, GA, ID, KS, LA, MI, MO, MS, MT, NE, NM, NV, OK, OR, TN, TX, UT, WY
The product has been distributed domestically
nationwide including Puerto Rico, U.S. Virgin Islands, and sold online at bulletproof.com. Products were distributed internationally in the following countries: Australia, Bahrain, Bermuda, Bolivia, Brazil, Brunei Darussalam, Canada, Cayman Islands, China, Finland, France, Germany, Guam, Hong Kong, Hungary, Iceland, Israel, Japan, Korea, Kuwait, Liechtenstein, Macau, Malaysia, Malta, Mexico, Monaco, Netherlands, New Zealand, Norway, Oman, Philippines, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
Product was distributed throughout the United States
Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Distributed to FL, VA, IL, NJ, WA and South Korea

Product Description
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
Ben & Jerry's Pint Slices Chocolate Fudge Brownie 3 chocolate ice cream bars Net 9 FL OZ. UPC code 076840657940
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Finola, Style Octopus in Pickled Sauce, Product of Spain, Wild Caught, Net Weight 4.1/10oz (115g), Empacado para:/Packaged for: Bacalafoods Corp., San Juan, PR 00936-8060
Finola, Style Octopus in Oil, Product of Spain, Wild Caught, Net Weight 4.1/10oz (115g), Empacado para:/Packaged for: Bacalafoods Corp., San Juan, PR 00936-8060
Finola, Style Octopus in Garlic, Product of Spain, Wild Caught, Net Weight 4.1/10oz (115g), Empacado para:/Packaged for: Bacalafoods Corp., San Juan, PR 00936-8060
Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (FC500, Navios and Navios EX). The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
Golden Temple No. 1 Fine Durum Atta Flour Blend NET WT 20 LB INGREDIENTS: DURUM WHEAT FLOUR, DURUM WHEAT BRAN, WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: SMUCKER FOODS OF CANADA CORP., MARKHAM, ON L3R 0P3 PRODUCT OF CANADA UPC 0 59000 40540
Flour sold under the following brands: Golden Temple Durum Atta Flour Blend, 20LB, DISTRIBUTED BY: SMUCKER FOODS OF CANADA CORP., MARKHAM, ON L3R 0P3 PRODUCT OF CANADA UPC 0 59000 41556 7, Swad Durum Atta Flour, 20 LB MILLED FOR: RAJA FOODS 8110 N. St. Louis Avenue Skokie, IL 60075 57-03, 48th Street Maspeth, NY 11378 PRODUCT OF CANADA, UPC 0 51179 16030 9 & Maya Durum Wheat Atta Flour, 20 LB, DISTRIBUTED BY: MAYA OVERSEAS FOODS INC. 48-85 MASPETH AVENUE MASPETH, N.Y. 11378 Product of Canada UPC 0 20843 10001 9 Ingredients: Durum Wheat Atta Flour, Durum Wheat Bran, Wheat Flour, Niacin, Reduced Iron, Thiamin Mononitrate, Riboflavin, Folic Acid.
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Taste of Inspirations; Greek Pasta Salad, Net Wt. 10 oz.; Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074;
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
600/CA Model No. SB 5021, Rx Only, Sterile EO.
Schnucks Bakery, Sliced Pudding Cake Tray, NET WT 2.00 lb (907 g)
1) Schnucks Bakery, Cinnamon Pudding Cake Slice, NET WT 6.0 oz (170 g); 2) Schnucks Bakery, Half Cinnamon Pudding Cake, NET WT 1.06 lb (482 g);
Nutri-Dyn Calcium D-Glucarate Plus, Dietary Supplement, 60 Capsules, UPC 7 13757-09611 9
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
SOUTH AFRICAN STYLE PERl PERl ROASTED SPICE PASTE INGREDIENTS: VINEGAR, JALAPENO PUR E;(jalapeno peppers, salt, vinegar), ONION, MINCED GARLIC (garlic, soybean oil, citric acid),PAPRIKA, CANOLA OIL, GRANULATED ONION, BIRDS EYE CHILl PEPPER, SALT,LEMON JUICE CONCENTRATE,SPICE, OIL OF LEMON AND ROSEMARY EXTRACT. PREPARED BY: EATEM FOODS CO. 1829 GALLAGHER DRIVE VINELAND, NEW JERSEY 08360 DIRECTIONS: 1-2% IN TYPICAL FORMULATION NET WEIGHT 50 lb. 22.7 kg., KEEP REFRIGERATED ' FOR FURTHER PROCESSING'
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16
Carrot Cake Slice: Net Wt. 0 LB 7 OZ (198 g). Cake is assembled, iced, sliced and packaged at store level. Sliced wrapped individually in clear plastic clamshell and sold in bakery department. UPC Code: 0222132-000000 Sold under Albertsons Companies retail banners of Vons, Pavilions, Lucky and Albertsons.
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Don's Salads; Egg Salad; Net Wt. 5 lbs., MFGD by Aldon Food Corp, Schwenksville, PA 19473; Sell by dates: 6/7, 6/9, 6/13, 6/15; UPC: 740247005061; AND; Block & Barrel Classic Egg Salad; Net Wt. 5 lbs; Distributed by Sysco Corporation, Houston, TX 77077; Sell By Dates: 6/7, 6/9, 6/13, 6/15; UPC: 074865655316;
Don's Salads; Chopped Herring Salad; Net Wt. 5 lbs., MFGD by Aldon Food Corp, Schwenksville, PA 19473; Sell By: 6/9, 6/11, 6/17, 6/24; UPC: 740247005023
Don's Salads; Magnum Shrimp Salad; Net Wt. 5 lbs., MFGD by Aldon Food Corp, Schwenksville, PA 19473; Sell By: 6/7, 6/12, 6/16, 6/26; UPC: 740247006013
Amodio's Toasted Coconut Panko sold in an 8 oz bags packaged in cases of 8.
Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.
33034 33116 Thick Cut Regular Batter: ATLANTIC GOLD STEAK CUT BATTERED ONION RINGS NET WT 10 lb (4.54 kg) - 33166
Small White Button Mushroom Regular Batter: ATLANTIC GOLD Battered Mushrooms Net Weight 5 lb (2.27 kg) - 34086; Atlantic Gold Battered Mushrooms 6 x 2 lbs 12 lbs - 34112;
ALE HOUSE BEER BATTERED 3/8 ONION RINGS - NET WT. 4/2.5 lb (1.13 kg) 10 lb (4.54 kg) - 33221
Beer Battered Onion Rings 4-40oz (2.5 lb) 1.13kg Packages (Net Weight 10 lb (4.54kg) - 33145; Bellissimo Beer Battered Onion Rings Net Weight 4 x 2.45 lbs 10 lbs - 33187
Thick Cut Beer Battered Onion Rings: ALE HOUSE BEER BATTERED STEAK CUT ONION RINGS NET WT. 10 lb (4.45 kg) - 33074
Gourmet Bay - Toasted Crumb Breaded Tilapia, 5-7 oz. (Bulk 5 lbs container) refrigerated Product Code: 7396701
Gourmet Bay - Honey Mustard Breaded Tilapia, 5-7 oz.. refrigerated (Bulk 5 lbs container) Product Code: 7324801
Gourmet Bay - Citrus Coconut Breaded Tilapia, 5-7 oz (Bulk 5 lbs) refrigerated Product Code: 7322401
Sabor Mexicano Homemade Corn Chips: Packaged in 12 oz. (9 units per case), UPC 8-53094-00417-7, and Fun size 5 oz. ( 12 units per case), UPC 8-53094-00418-4.
Giant Eagle; Toasted Crumb Tilapia; various weights; Dist. By: Giant Eagle, Inc., Pittsburgh, PA PLU #69123. UPC: 691237 0054548
Chili Pequino 0.25 oz packaged in a clear plastic bag; Product Code 10106
Sea Watch Brand Beer Battered Clam Strips Pack Size: 24/4 oz. bags/case
Sea Watch Beer Battered Clam Strips Pack Size: 2/3 lb. bags/case
Sailors Choice Breaded Clam Strips Pack Size: 24/6 oz. bags/case
Sailors Choice Brand Breaded Clam Strips Pack Size: 24/4 oz. bags/case
Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11
StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
Fudge Brownie Collagen Protein Bar. Each bar is packed in foil wrapper, net wt. per bar 1.58 oz (45g). There 12 bars packed in a box and the net wt. per box is 18.96 oz (540g). Individual Bar UPC 815709021498. Box UPC 815709020811.
Fudge Brownie Collagen Protein Bite. Each Bite is packed in foil wrapper, net wt. per Bite 0.74 oz (21g). There 15 pieces packed in a box and the net wt. is 11.10 oz (315 g). Individual Bar UPC 815709021528. Box UPC 815709021535.
Vanilla Shortbread Collagen Protein Bite. Each Bite is packed in foil wrapper, net wt. per Bar is 0.74 oz (21g). There 15 pieces packed in a box and the net wt. is 11.10 oz (315 g). Individual Bar UPC 815709021504. Box UPC 815709021511.
Lemon Cookie Collagen Protein Bar. Each Bar is packed in foil wrapper, net wt. per Bar is 1.58 oz (45g). There 12 bars packed in a box and the net wt. is 18.96 oz (540g). Individual Bar UPC 815709021801. Box UPC 815709021795.
Vanilla Shortbread Collagen Protein Bar. Each Bar is packed in foil wrapper, net wt. per Bar is 1.58 oz (45g). There 12 bars packed in a box and the net wt. is 18.96 oz (540g). Individual Bar UPC 815709021481. Box UPC 815709020804.
MEIJER CASHEWS TOASTED COCONUT 8.25 OZ plastic pouch
MEIJER ULTRA TRAIL MIX 18 OZ plastic pouch
go macro THRIVE Chocolate, Nuts & Sea Salt bar, Net Wt 1.4 oz / 40 G, UPC 8 53555-00650 4
go macro MACROBAR, coconut + almond butter + chocolate chips, in the following sizes: 1. Net Wt 0.9 oz / 25 G minbar, UPC 8 53555-00671 9 and 2. net Wt 2.3 oz / 65 G, UPC 8 53555-00668 9
go macro THRIVE Caramel Coconut bar, Net Wt 1.4 oz / 40 G, UPC 8 53555-00652 8
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
Proteus 235 and Proteus ONE proton therapy systems
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.

Reason for Recall
A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Software bug which allows parameters to be changed unintentionally during use.
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.
Unilever is voluntarily recalling a limited number of boxes of Ben & Jerry's Chocolate Fudge Brownie Pint Slices due to undeclared peanut.
Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.
Product in principal display panel identified as Style Octopus while real content is squid.
When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.
Labeling: Incorrect or Missing Lot and/or Exp Date
The firm was notified by their Co-packer that the product may be contaminated with E. coli.
CGMP Deviations: Lack of quality assurance at the API manufacturer.
A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Hannaford Supermarkets TASTE OF INSPIRATIONS GREEK PASTA SALAD Net Wt. 10 oz. (284g) because it may contain undeclared milk. The recall was initiated after it was discovered that certain packages of the recalled product contained an ingredient and nutrition label from another product [Taste of Inspirations Classic Red Skin Potato Salad] that did not reveal the presence of milk.
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
The scale label generated for cake slices at the store level fails to declare the slices contain walnuts
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
During production of St. John's Wort, Lot 160876, a number of bottles were mistakenly labeled as Calcium D-Glucarate Plus
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
Eatem was notified by a supplier that it was recalling a Chilles product used by Eatem foods as an ingredient in a spice blend product because peanut allergen was detected in the Chilles products.
Blood product, in which quality control and distribution of product did not meet specifications, was distributed.
Discovered through the complaint process that the ingredient list for carrot cake slices did not include walnuts in the ingredient or allergen statement. Nuts are visible through packaging.
Blood products, in which quality control and distribution/testing not performed, incompletely performed, or not documented, were distributed.
May result in elevated platelet backgrounds during routine startup/background checks.
One lot of product does not include a screw for attachment to the tibial base plate.
Don's Salads is recalling egg salads due to undeclared milk. An ingredient, used in the manufacture of the salads, has been recalled due to undeclared milk.
Don's Salads is recalling Chopped Herring Salad due to undeclared milk. An ingredient, used in the manufacture of the salads, has been recalled due to undeclared milk.
Don's Salads is recalling Magnum Shrimp Salad due to undeclared milk. An ingredient, used in the manufacture of the salads, has been recalled due to undeclared milk.
Product was improperly labeled leading to improper storage.
Products recalled due to undeclared allergen -milk
Blood products, which did not meet the acceptable product specifications, were distributed.
A typographical error was found on the sodium content of Sabor Mexicano Homemade Corn Chips; label listed 15 mg of sodium when the correct amount was 250 mg.
The product has been recalled because it may contain undeclared milk.
Sea Watch International used blended bread coating that is being recalled due the potential presence of undeclared milk. Milk is not declared as an allergen or in an advisory statement on Sea Watch breaded clam strips labels.
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Fudge Brownie Collagen Protein Bar product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Fudge Brownie Collagen Protein Bite is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Vanilla Shortbread Collagen Protein Bite product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Lemon Cookie Collagen Protein Bar product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Vanilla Shortbread Collagen Protein Bar product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Coconut not listed in FALCPA Contains statement while a Contains statement is present on the label
GoMacro is recalling specific MacroBars and Thrive Bars because they may be contaminated with Listeria monocytogenes.
Cross Contamination With Other Product: Imipramine
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Presence of Foreign Substance: possibility of the presence of metal in the product.

Code Info
Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
best by date AUG1218LT2 and lot number of AUG1218LT2.
All serial numbers currently in the field
Lot Number, 6286548, Best If Used By 18-Jan & Lot Number, 6299548, Best If Used By 18-Jan
Maya - Lot Numbers, 6286548, & Lot Numbers, 6287548; Swad - Lot Numbers, 6294548, Lot Numbers, 6299548, Lot Numbers, 6300548, & Lot Numbers, 6308548, Golden Temple - Lot Numbers, 6287548, Best If Used By: 18-Jan, Lot Numbers, 6288548, Best If Used By: 18-Jan, Lot Numbers, 6294548, Best If Used By: 18-Jan, Lot Numbers, 6295548, Best If Used By: 18-Jan, Lot Numbers, 6300548, Best If Used By: 18-Jan, Lot Numbers, 6301548, Best If Used By: 18-Jan, Lot Numbers, 6306548, Best If Used By: 18-Jan, Lot Numbers, 6307548, Best If Used By: 18-Feb & Lot Numbers, 6308548, Best If Used By: 18-Feb
All date codes up to and including 6/12/17.
Lot/Unit Numbers: Lot #s 027836 & 027897
Produced between the dates of January 31, 2017 and June 6, 2017.
Various weights, various Sell By March 10- June 9 2017; PLU #69123; UPC: 691237 005548.
Production Date: March 30, 2017 Production Code/Lot Number: E03307 Shelf Life: 12 months stored under specified frozen conditions. Best By Date: March 30, 2018 Production Date: April 3, 2017 Production Code/Lot Number: E04037 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 3, 2018 Production Date: April 15, 2017 Production Code/Lot Number: E04157 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 15, 2018 Production Date: April 22, 2017 Production Code/Lot Number: E04227 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 22, 2018 Production Date: April 26, 2017 Production Code/Lot Number: E04267 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 26, 2018
Production Date: March 30, 2017 Production Code/Lot Number: E03307 Shelf Life: 12 months stored under specified frozen conditions Best By Date: March 30, 2018 Production Date: April 3, 2017 Production Code/Lot Number: E04037 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 3, 2018 Production Date: April 22, 2017 Production Code/Lot Number: E04227 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 22, 2018 Production Date: May 5, 2017 Production Code/Lot Number: E05057 Shelf Life: 12 months stored under specified frozen conditions Best By Date: May 5, 2018
Production Date: April 15, 2017 Production Code/Lot Number: E04157 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 15, 2018
Production Date: April 15, 2017 Production Code/Lot Number: E04157 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 15, 2018 Production Date: April 26, 2017 Production Code/Lot Number: E04267 Shelf Life: 12 months stored under specified frozen conditions Best By Date: April 26, 2018
Lot Code / Best By Date: 3568 / 2/6/2018.
Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003