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U.S. Department of Health and Human Services

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Changes to Past Enforcement Reports

FDA endeavors to provide the most accurate and up-to-date data pertaining to recalls and enforcement actions. In this effort, we recognize the need to modify or expand the recall and enforcement data disclosed in the Enforcement Report when new information becomes available. In addition to modifying the specific recall with the correct information in a past Enforcement Report, we recognize it is important for the public to be aware of such changes.  The table posted to this page supplies information to identify modified recalls, when the recall was initially published to the internet, and the data corrected.

Please email us at webmail@oc.fda.gov with your feedback.

  • Changes to the April 30th 2014 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Food/Cosmetics68002F-1885-2014American Pop Corn CoJolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873 American Pop Corn Company, Sioux City, IA.Code InfoBest By Code 04/01/15 (Julian date) 4091

  • Changes to the March 12th 2014 Enforcement Report 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Food/Cosmetics67299Applies to All Recalled ProductsRise'n Roll Bakery
Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties: White Powdered Donut : Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) COATING: Dextrose, cornstarch, partially hydrogenated vegetable oil, titanium dioxide, rice flour, hydrogenated cottonseed oil, artificial flavor, silicon dioxide. Contains wheat, soy and milk
Quantity DistributedUnknown
 Food/Cosmetics67534Applies to All Recalled ProductsFalafel King Ent
Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile hummus GF 100% NATURAL**
Quantity Distributed4000 total, for all varieties

  •  Changes to the February 19th 2014 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Biologics67032B-0273-14OneBlood, Inc.Fresh Frozen PlasmaNEW RECALLED PRODUCTNEW RECALLED PRODUCT
 Biologics67032B-0274-14OneBlood, Inc.Red Blood Cells Leukocytes ReducedNEW RECALLED PRODUCTNEW RECALLED PRODUCT

  • Change to the November 27 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices66773

 

Z-0348-2014

Candela CorporationCandela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040Distribution PatternWorldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom.

  • Change to the November 6th, 2013 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices66383Z-0113-2014Beckman Coulter Inc.COULTER® LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.Reason for RecallBeckman Coulter internal investigation indicated that specific lots of check valves used in several locations within the LH 750 and LH 780 analyzers may fail. This failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. Source of initial complaint: Customer laboratory in the United States.
 Food/Cosmetics66445Applies to all Recalled ProductsAmerican Laboratories IncApplies to all Recalled ProductsClassificationClass II

 

  • Change to the October 30th, 2013 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Biologics36297Applies to all recalled products(see New Information)Applies to all recalled productsRecalling FirmSouth Florida Blood Banks, Inc.

 

  • Changes to the October 9th, 2013 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Food/Cosmetics65111F-1959-2013Novartis Consumer HealthBenefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 18.7-oz. (115 servings) bottles, UPC 300670068158. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, Made in France.Product Quantity226,381 consumer units
 Food/Cosmetics65111F-1960-2013Novartis Consumer HealthBenefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.4-oz (48 servings) bottles, UPC 300673002487. Distributed by: Novartis Consumer health, Inc., Parsippany, NJ 07054-0622. Made in France.Product Quantity170,220/6.4-oz. (48 servings) bottles
 Food/Cosmetics65111F-1961-2013Novartis Consumer HealthBenefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670107246. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.Product Quantity162,408/5.0-oz. (24-ct) boxes
 Food/Cosmetics65111F-1962-2013Novartis Consumer HealthBenefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.Product Quantity152,016/5.0-oz. (24-ct) boxes
 Food/Cosmetics65111F-1963-2013Novartis Consumer HealthBenefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.Product Quantity110,664/10.76-oz (48 Servings) bottles

 

  • Changes to the October 2nd, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Biologics43057B-2160-13International BioResources, LLCSource PlasmaDistribution PatternNorth Carolina
 Devices65981Z-2261-2013Terumo Cardiovascular Systems CorporationTerumo® Pall AL6X Arterial Blood Line Filter, labeled in part ***Terumo Cardiovascular Systems Corporation Elkton, MD 21921***, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo® Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo® Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.Code InfoRecalled filters sold singly are identified with Part Number AL6X with the following lot codes: MM19, MN23, NC15, ND01, ND08, ND29, NE11, NE18, NE25, NF09, NF31, PA23, PD05, PE02, PF14, PF21, PG04, PG11, PG18, PG25, PH09, PH16, PH30, PK06, PK13, PL24, PM01, PM08, PM22, PM29, PN12, PN26, PP17, PP31, QA07, QA14, QA21, QC04, QC25, QD11, QD18, QD25, QE08, QE15, QE22, QE29, QF06, QF28, MM26, NL12, NM24, NP12, and PA30; Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes: PN19, QA14, QC11R, QD04, QE15, QF06, QF13, NM31, NP05, PC20, PD05, QF28, QC04, PD26, PG04, PE23R, PK13, PK20, QA21, QC11, QC11A, QD11, QE01, PL17, QE08, NK08, PG25, PN26, QC18, NN07, NN07R, PA16, PA16R, PC27, PC27R, PF07, PL24, PD12, PE09, PE30, PH09, PL10, PE23, PF14, PG18, PK06, PM01, PM22, PN12, QA02, QA28, QC25, QD25, NK01, NK08R, PH23, PH16, PL10A, PM15, PP10, PP17, QD18, QE22, NM17, NM17A, PC06, PC06R, PE09R, QE01A, QE15A, QE15T, QE15TA, QE15TC, QF13T, QF20, QF20T, NA10R, NA17R, ND14, ND28, ND28T, NE11T, NE18, NF23, NG06, NG20, NH11, NH18, NK15, NL12, NL26, NM03, NM10, NM24, NN14, NN28, NP12, PA30, PC13, PD19, PE16, PF07A, PF21, PK27, PK27A, PL04, PM08, PP03, QA14T, QE29, QF28T, QF28TA, PG11, PH30, PH30A, PN26A, QA07, NH25, NK29, PE02, PF29, PN19, QG17, PK13A, QD11A, MN22, NE25, NF31, PM29, PA09, QG03, PA02, PH23T, PG11T, QC18R, QF06A, PH09T, PH09TA, QF13TA, QF20TA, and QF20TC

 

  • Change to the September 25th, 2013 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Food/Cosmetics66013F-1904-2013Novartis Consumer HealthBenefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.Code InfoLot Number and Expiration date (36ct bottle): 10117915, 5/31/2014; 10118335, 7/31/2014; 10120615, 9/30/2014; 10110703A 3/31/2014. (100ct bottle): 10110706, 2/28/2014; 10112140, 2/28/2014; 10113261, 5/31/2014; 10116530, 5/31/2014; 10120059, 7/31/2014; 10120616, 8/31/2014; 10125996, 9/30/2014 and 10109551, 3/31/2015.
 Food/Cosmetics66013F-1904-2013Novartis Consumer HealthBenefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottles. Novartis Consumer Health, Inc, Parsippany, NJ.Product Quantity165,480 units

 

  • Change to the September 11th, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Biologics65538B-1831-13Blood Systems, Inc. dba United Blood Services TexasBlood and Blood Products for ReprocessingReason for RecallBlood products, collected from an ineligible donor, were distributed.

 

  • Change to the August 14th, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices65653Z-1933-2013SpineFrontier, IncIndus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place.Code InfoLot Numbers: 7140.014; 6486.008 Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R

 

 

 

  • Change to the August 7th, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices65084Z-1831-2013Wako Life Sciences, Inc.uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated system and each assay performed on a single disposable chip using microfluidic electrophoretic separation. The reagent cartridge contains various buffers and antibodies.Distribution PatternDistribution to CA, GA, MN, NC, UT and the District of Columbia.

 

  • Change to the July 31st, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Biologics59414B-1561-13Talecris Plasma Resources, Inc.Source PlasmaRecall Initiation Date05-Jul-11
 Devices65504Z-1772-2013Ethicon Endo-Surgery IncEndopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.Code InfoProduct Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03.

 

  • Change to the July 24th, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Drugs65512D-804-2013Fresenius Kabi USA, LLC Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.Reason for RecallSubpotent Drug; 15-month stability test station

 

  • Change to the July 3rd, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Drugs61918D-611-2013Hospira Inc.0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045Code InfoLot #: a) 89-135-JT, 04-224-JT, 07-138-JT, Exp 4/13, 08-160-JT Exp. 8/13 ; b) 08-163-JT, 90-036-JT, 02-048-JT, Exp 2/13; c) 93-102-JT, 11-063-JT, Exp 9/12; d) 93-096-JT, Exp 11/12
 

  • Changes to the June 5th, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices65031 Applies to All Recalled ProductsIntel-GE Care Innovations LLCApplies to All Recalled Products Distribution PatternUS and Great Britain
 Devices65094 Z-1424-2013Intuitive Surgical, Inc.User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery. Distribution PatternUS Distribution Only

 

  • Change to the May 22nd, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices 64986 Z-1324-2013Varian Medical Systems, Inc. Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. Distribution Pattern Worldwide Distribution in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
 Drugs 64995 D-331-2013Glenmark Generics Inc., USA Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 Product DescriptionGlenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430

  

 

  • Change to the April 24th, 2013 Enforcement Report

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Devices64700Z-1123-2013Advanced Sterilization ProductsEVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.Code InfoSerial Numbers: 5041110026 5041110070 5041110041 5041110082 5041110083 5041110076 5041110075 5041110078 5041110085 5041110092 5041110091 5041110077 5041110079 5041110086 5041110081 5041110084 5041110080 5041110087 5041110105 5041110099 5041110104 5041110101 5041110088 5041110106 5041110090 5041110093 5041110110 5041110108 5041110115 5041110112 5041110116 5041110114 5041110107 5041110074 5041110102 5041110111 5041110113 5041110098 5041110100 5041110071 5041110073 5041110117 5041110123 5041110122 5041110124 5041110125 5041110126 5041110109 5041110127 5041110120 5041110129 5041110130 5041110134 5041110128 5041110135 5041110143 5041110136 5041110137 5041110121 5041110140 5041110132 5041110131 5041110144 5041110145 5041110141 5041110146 5041110133 5041110142 5041110147 5041110148 5041110150 5041110151 5041110152 5041110156 5041110149 5041110157 5041110153 5041110154 5041110155 5041110158 5041110159 5041110160 5041110161 5041110162 5041110171 5041110164 5041110172 5041110173 5041110175 5041110163 5041110176 5041110177 5041110179 5041110178 5041110180 5041110182 5041110185 5041110184 5041110183 5041110186 5041110187 5041110189 5041110190 5041110192 5041110174 5041110191 5041110194 5041110195 5041110196 5041110188 5041110199 5041110197 5041110198 5041110205 5041110200 5041110206 5041110203 5041110207 5041110208 5041110211 5041110210 5041110216 5041110209 5041110225 5041110220 5041110218 5041110227 5041110219 5041110229 5041110212 5041110215 5041110223 5041110224 5041110221 5041110214 5041110226 5041120061 5041120065 5041120057 5041120064 5041120059 5041120069 5041120063 5041120072 5041120074 5041120066 5041120068 5041120070 5041120073 5041120076 5041120078 5041120079 5041120075 5041120077 5041120080 5041120084 5041120092 5041120096 5041120094 5041120071 5041120086 5041120089 5041120090 5041120088 5041120093 5041120095 5041120098 5041120103 5041120101 5041120091 5041120097 5041120104 5041120062 5041120105 5041120099 5041120085 5041120102 5041120108 5041120060 5041120107 5041120100 5041120106 5041120087 5041120116 5041120114 5041120113 5041120112 5041120111 5041120081 5041120067 5041120109 5041120118 5041120123 5041120110 5041120119 5041120125 5041120126 5041120117 5041120129 5041120132 5041120115 5041120127 5041120131 5041120121 5041120122 5041120130 5041120124 5041120133 5041120139 5041120136 5041120140 5041120137 5041120138 5041120157 5041120158 5041120159 5041120160 5041120161 5041120162 5041120163 5041120164 5041120165 5041120148 5041120149 5041120152 5041120153 5041120154 5041120155 5041120151 5041120150 5041120120 5041120169 5041120168 5041120176 5041120172 5041120141 5041120156 5041120142 5041120147 5041120146 5041120171 5041120145 5041120175 5041120181 5041120170 5041120173 5041120177 5041120183 5041120180 5041120182 5041120197 5041120179 5041120178 5041120190 5041120193 5041120184 5041120191 5041120196 5041120199 5041120192 5041120201 5041120203 5041120200 5041120194 5041120174 5041120198 5041120195 5041120185 5041120213 5041120206 5041120214 5041120208 5041120209
 Drugs64846D-248-2013Actavis South Atlantic LLCbuPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.Code InfoLot #: CC1D11A, CC1D12A, CC1D17A, CC1D18A, CD1D05A, CD1D07A, CD1D08A, CD1D14A, CD1D15A, CD1D16A, CE1D08A, Exp 03/13; CE1D03A, CE1D04A, CE1D07A, CE1D06A, CE1D05A, CE1D13A, CE1D14A, CE1D15A, Exp 04/13; CF1D01A, CE1D24A, CF1D02A, Exp 05/13; CH1D08A, CH1D09A, Exp 07/13; CJ1D01A, CH1D11A, CH1D10A, CJ1D09A, CJ1D02A, CJ1D10A Exp 08/13; CL1D05A, CL1D06A, CK1D05B, CK1D06A, Exp 10/13; CL1D08A, CM1D01A, CM1D02A, Exp 11/13

 

  • Changes to the March 20th, 2013 Enforcement Report 

     Product Area/CommodityRecall Event Number Recall Number Recalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
     Biologics64211B-1051-13 Smiths Medical ASD, Inc. Level 1 Fast Flow Fluid Warmer's without air detection Reorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V N/AN/A
    Recall Event 64211 is now displayed in both the Biologics and Devices product areas. NOTE: The recall will show up twice in the All Recalls tab and the downloadable CSV.
     
     Food/Cosmetics64555F-1140-2013 Riggio Dist Co Product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Routine testing by the Michigan Department of Agriculture revealed the presence of Listeria Monocytogenes in a single 16 ounce package of "Mixed Blend" Greens. ClassificationClass II
     Food/Cosmetics64555F-1140-2013Riggio Distr Co Product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Routine testing by the Michigan Department of Agriculture revealed the presence of Listeria Monocytogenes in a single 16 ounce package of "Mixed Blend" Greens.Code InfoLot 171853 UPC 3639320605 Use By 3/5/13

 

  • Change to the March 6th, 2013 Enforcement Report

 

 Product Area/CommodityRecall Event NumberRecall NumberRecalling FirmProduct DescriptionColumn/Row Name (with the Corrected Data)New Information
 Food/Cosmetics 64384 F-1022-2013Koda Farms Inc. Mochiko Blue Star Sweet Rice Flour; Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665 Code Info Product code 3F13 and 3F14 (produced January 13 and 1, 2013.