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)
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.
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
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.
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
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #:  321-05-46
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.
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
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.
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.
Software bug which allows parameters to be changed unintentionally during use.
Worldwide Distribution - USA (nationwide) and to the countries of :  Europe, Australia, New Zealand,  South Africa, Greater Asia, Middle East, and Canada.
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.
Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
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.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
best by date AUG1218LT2 and lot number of AUG1218LT2.
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.
Potential for electric shock in the case of a failure to install the grommets, supplied with the system.
US Distribution to the states of : IN, MI, IA
Sensis Vibe Systems with Software Version VD10B,  Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
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.
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
Product in principal display panel identified as Style Octopus while real content is squid.
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.
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.
All serial numbers currently in the field
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
Labeling: Incorrect or Missing Lot and/or Exp Date
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
Product was sent to the following states: CA, FL, GA, IL, KS, MD, MI, NC, NJ, NY, TX, VA & WA.
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
The firm was notified by their Co-packer that the product may be contaminated with E. coli.
Lot Number, 6286548, Best If Used By 18-Jan & Lot Number, 6299548, Best If Used By 18-Jan
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.
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
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
CGMP Deviations:  Lack of quality assurance at the API manufacturer.
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
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.
600/CA Model No. SB 5021, Rx Only, Sterile EO.
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.
Schnucks Bakery, Sliced Pudding Cake Tray, NET WT 2.00 lb (907 g)
The scale label generated for cake slices at the store level fails to declare the slices contain walnuts
All date codes up to and including 6/12/17.
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);
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
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
Nutri-Dyn Calcium D-Glucarate Plus, Dietary Supplement, 60 Capsules, UPC 7 13757-09611 9
During production of St. John's Wort, Lot 160876, a number of bottles were mistakenly labeled as Calcium D-Glucarate Plus
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
Failed Impurities/Degradation   Specifications; out of specification result for Acetonitrile residual solvent
Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of:  INDIA and GERMANY.
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.
Mis-pack.  A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
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.
All product was shipped to Canada.    Monfitello, Inc.  2700 Jean-Baptiste-Deschamps  Machine, Quebec H8T1E1 Canada
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'
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.
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
Blood product, in which quality control and distribution of product  did not meet specifications, was distributed.
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.
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.
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
May result in elevated platelet backgrounds during routine startup/background checks.
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
One lot of product does not include a screw for attachment to the tibial base  plate.
Aldon Food Corp. dba Don's Salads & Don's Food Products
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 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; 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 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; 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
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.
Amodio's Toasted Coconut  Panko sold in an 8 oz bags packaged in cases of 8.
Worldwide Distribution to the country : UK
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.
Product was improperly labeled leading to improper storage.
RI, ME, NY, CT, PA, VA, NJ, MA, NC, WI, NH
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
Products recalled due to undeclared allergen -milk
Produced between the dates of January 31, 2017 and June 6, 2017.
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
Blood products, which did not meet the acceptable product specifications, were distributed.
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.
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.
Giant Eagle; Toasted Crumb Tilapia; various weights; Dist. By: Giant Eagle, Inc., Pittsburgh, PA    PLU #69123. UPC: 691237 0054548
The product has been recalled because it may contain undeclared milk.
Various weights, various Sell By March 10- June 9 2017;   PLU #69123; UPC: 691237 005548.
US. AR, AZ, CO, GA, ID, KS, LA, MI, MO, MS, MT, NE, NM, NV, OK, OR, TN, TX, UT, WY
Chili Pequino 0.25 oz packaged in a clear plastic bag; Product Code 10106
The product has been distributed domestically
Sea Watch Brand Beer Battered Clam Strips   Pack Size:  24/4 oz. bags/case
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.
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
Sea Watch  Beer Battered Clam Strips  Pack Size:   2/3 lb. bags/case
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
Sailors Choice  Breaded Clam Strips   Pack Size:  24/6 oz. bags/case
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
Sailors Choice Brand  Breaded Clam Strips  Pack Size:   24/4 oz. bags/case
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
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
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.
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
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.
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 Bar product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
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.
Fudge Brownie Collagen Protein Bite is recalled because it has the potential to be contaminated with Listeria monocytogenes.
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.
Vanilla Shortbread Collagen Protein Bite product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
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.
Lemon Cookie Collagen Protein Bar product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
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.
Vanilla Shortbread Collagen Protein Bar product is recalled because it has the potential to be contaminated with Listeria monocytogenes.
MEIJER CASHEWS TOASTED COCONUT 8.25 OZ  plastic pouch
Coconut not listed in FALCPA Contains statement while a Contains statement is present on the label
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
GoMacro is recalling  specific MacroBars and Thrive Bars because they may be contaminated with Listeria monocytogenes.
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
Lot Code / Best By Date:  3568 / 2/6/2018.
Product was distributed throughout the United States
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
Cross Contamination With Other Product: Imipramine
Fagron Compounding Services LLC dba Fagron Sterile Services
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
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
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.
Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Proteus 235 and Proteus ONE proton therapy systems
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Distributed to FL, VA, IL, NJ, WA and South Korea
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.
Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003
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.
Presence of Foreign Substance: possibility of the presence of metal in the product.