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U.S. Department of Health and Human Services

Enforcement Report - Week of September 18, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 103692448(Part A) ;103692448(Part B) Class III Blood products, which failed to meet the minimum specification for percent red blood cell recovery, were distributed. Blood Systems, Inc.
Biologics Fresh Frozen Plasma 4023161 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HemaCare Corporation
Biologics Red Blood Cells Leukocytes Reduced 4023161 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. HemaCare Corporation
Biologics Source Plasma 0210038593 0210041652 Class III Blood products, collected from a donor who was deferred for unknown reasons, were distributed. Biomat USA, Inc.
Biologics Fresh Frozen Plasma 0815664;0815603;6818886;0815374; 6819007;0500545;0709999;6819018; 6819021;3400181 Class III Blood products, which were not manufactured in accordance with required specifications, were distributed. LifeShare Community Blood Services
Biologics Red Blood Cells Leukocytes Reduced 1613444, 1190847 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Fresh Frozen Plasma 1613444, 1190847 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells FW04380 Class II Blood products, collected from a donor who was previously deferred, were distributed.. HemaCare Corporation
Biologics Fresh Frozen Plasma FW04380 Class II Blood products, collected from a donor who was previously deferred, were distributed.. HemaCare Corporation
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 16KF51806 Class II Blood Products, collected in an apheresis kit which was not used within the specified time period after priming, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma (Apheresis) 16KF51806 Class II Blood Products, collected in an apheresis kit which was not used within the specified time period after priming, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 42H50733 Class III Blood products, collected from donors who answered a donor screening question inappropriately, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 42H50733 Class III Blood products, collected from donors who answered a donor screening question inappropriately, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 103674108;103671378 Class III Blood products, for which storage conditions and shipment information were undocumented, were distributed. Blood Systems, Inc.
Biologics Source Plasma 07KINE8542;07KINE9460 Class III Blood products, which were collected from a donor with a history of high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Blood and Blood Products for Reprocessing GP89735; GP70416; GN17495; GP02047; GN88510; GN70079; GN10205; GM97295; GM74549; GM38976 Class III Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced GC46798; GP89735; GP70416; GP42867; GP02047; GN88510; GN70079;GN37152;GN17495; GN19682; GN10205; GM97295; GM74549; GM59314; GM38976 Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Plasma GC46798; GP42867; GN37152 Class II Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Source Plasma JK0207049; JK0207246;J K0209375; JK0209743; JK0210576; JK0210963;JK0211892. Class II Blood products, collected from a donor who had been incarcerated, were distributed. DCI Biologicals Orlando LLC
Biologics Red Blood Cells Leukocytes Reduced 01FC88762; 01FC88764; 01FC88766; 01FC88771; 01FC88772; 01FC88774; 01FC88776; 01FC88778; 01FC88779; 01FC88783; 01FC88785; 01FC88789; 01FC88792; 01FC88794; 01GN39856; 01GN39859; 01GN39865; 01GN39872; Class II Blood products, which were collected in a collection system that may have a potential defect which could compromise the sterility of the closed system, were distributed. American National Red Cross (The)
Biologics Source Plasma 4270131198 4270126026 4270125650 4270124675 4270123899 4270123349 4270120829 4270120275 4270119111 4270118841 4270117389 4270116685 4270116205 4270114575 4270113536 4270112879 4270112068 4270111435 4270110678 4270109408 4270108850 4270107652 4270107163 4270104462 4270104089 4270102250 4270101577 4270101081 4270099507 4270098917 4270097255 4270096380 4270095330 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 13183523 ;13175085 ;13168735 ;13161873 ; 13149529 ;13144951 ;13136185 ;13131777 ; 13123475 ;13110871 ;13105921 ;13096656 ; 13088040 ;13083311 ;13073510 ; 13068509 ; 13027452 ;13023836 ;0480863161 ; 0480872491 ;0480872084 ;0480871308 ;0480870930 ; 0480870268 ; 0480869890 ;0480869143 ;0480868789 ; 0480868054 ;0480867534 ;0480867025 ;0480866515 ; 0480865237 ; 0480864907 ;0480864154 ;0480863894 ; 0480862557 ; 0480862298 ;0480861467 ;0480881859 ; 0480880481 ;0480879724 ;0480879366 ;0480878258 ; 0480877707 ;0480877131  ...
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Class III Blood products, collected from donors who were permanently deferred, were distributed. CSL Plasma, Inc.
Biologics Source Plasma 4270184198 ;4270183448 ;4270179635 ;4270175391 ; 4270174464 ;4270168950 ;4270167538 ;4270166525 ; 4270162628 ;4270162160 ;4270159773 ;4270138087 ; 4270133013 ;4270114669 ;4270113260 ;4270111020 ; 4270109932 ;4270109507 ;4270012058 ;4270011007 ; 4270010201 ;4270008634 ;4270008244 ;4270008090 ; 4270332403 ;4270331378 ;4270328816 ;4270327720 ; 4270323319 ;4270321643 ;4270321171 ;4270318101 ; 4270317314 ;4270314489 ;4270310059 ;4270303513 ; 4270302528 ;4270300513 ;4270282182 ;4270253496 ; 4270252636 ;4270250858 ;4270248635 ;4270247679 ; 4270246438 ;4270245375 ;4270244076 ;4270243129 ; 4270241947  ...
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Class III Blood products, collected from donors who were permanently deferred, were distributed. CSL Plasma, Inc.
Devices Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580. Multiple serial numbers affected. Affected serial numbers were notified of this field correction. Class II This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes are performed on the pump key panel while the user is in the Dose Data Entry screen, or in specific circumstances when the HOLD key is used to silence the KYO alarm at the end of a DOSE Mode infusion. The issue can potentially be observed in Outlook ES pump models 100ES, 200ES, 300ES and 400ES with management processor software versions prior to 151580. It is possible that an under or overdose situation could occur because the user can inadvertently remove previously programmed dose limit values for the selected drug and user notification will not be generated if these dose values are exceeded. B. Braun Medical Inc. has identified that not all of the affected Outlook ES pumps were listed in the original notification of this field correction. Although these pumps were not identified in the previous notice, these pumps were upgraded, if available, during a routine field service. This follow up notification is to ensure that all pumps have been identified. B Braun Medical, Inc.
Devices Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. Class II B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels manufactured prior to October 17, 2011, key panel revision D. It is possible that if the HOLD button does not function properly when used to stop delivery during an infusion or to extend the hold time, it could lead to adverse health consequences in some patients. B Braun Medical, Inc.
Devices Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. Models 620-100 and 620-200; multiple serial numbers Class II B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on the drug library for dosing recommendations or to detect an inappropriate dose. This field correction was originally classified as a non-reportable field upgrade but is now being filed with the FDA as a reportable event. B Braun Medical, Inc.
Devices Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment. Serial Numbers: OH4-84712, OH4-84812, OH4-84912 Class II The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Leica Microsystems (Schweiz) Ag
Devices Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment. Serial Numbers: OH5-45912, OH5-46012, OH5-46112, OH5-46212, OH5-46312, OH5-46412, OH5-46512, OH5-46612, OH5-46712, OH5-46912, OH5-47012, OH5-47112, OH5-47212, OH5-47312, OH5-47412, OH5-47512, OH5-47612, OH5-47812, OH5-47912, OH5-48012, OH5-48112, OH5-48212, OH5-48312, OH5-48312 Class II The brake in the Z axis and/or brakes in the AB and C axes failed during installation. Leica Microsystems (Schweiz) Ag
Devices Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures. All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091 Class II A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. Xlumena, Inc.
Biologics Fresh Frozen Plasma W036810255463; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036810255463; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W140913280381 Part 1; W140913280381 Part 2; W140913280381 Part 3; Class II Blood products, which did not meet the acceptable product specifications, were distributed. South Texas Blood & Tissue Center
Biologics Platelets Pooled Leukocytes Reduced W036812848389; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W036812618065; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036812618065; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W036812543028; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036812859838; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma W036812543028; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood / dba CBCF
Biologics Platelets Pheresis Leukocytes Reduced W044413200831; Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. Northern Illinois Blood Bank dba Rock River Valley BC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W044413200831; Class II Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed. Northern Illinois Blood Bank dba Rock River Valley BC
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036512076526 Part 1; W036512076526 Part 2; W036512059908; Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. LifeShare Blood Centers
Biologics Fresh Frozen Plasma W087912651563; W087912605484; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Fresh Frozen Plasma W087912651563; W087912605484; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Blood and Blood Products for Reprocessing 036GW30440; Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells Leukocytes Reduced 2388428; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated 2909013; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W224312328079; W224312328026; W224312328027; W224312328029; W224312328035; W224312328036; W224312328038; W224312328044; W224312328045; W224312328048; W224312328052; W224312328073; Class III Blood products, which did not meet acceptable product specifications, were distributed. Houchin Blood Services
Biologics Fresh Frozen Plasma W036811231873; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036811231873; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated W036913208344; W036913208349; W036913208924; Class III Blood products, which were labeled with incorrect expiration dates, were distributed. Blood Bank Of Delmarva, Inc
Biologics Red Blood Cells 1446134; 1560763; 1684061; 1670207; 2083904; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma 1446134; 1570308; 1684061; 1670207; 2083904; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets 1570308; 1684061; 2083904; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced 1570308; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells W036809163266; Class II Blood product, collected from an inelgible donor, was distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036809801545; Class II Blood product, collected from an inelgible donor, was distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036809163266; Class II Blood product, collected from an inelgible donor, was distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812850044; Class II Blood product, collected fron an ineligible donor, was distributed. OneBlood / dba CBCF
Biologics Blood and Blood Products for Reprocessing W036812623250; Class III Blood product, collected fron an ineligible donor, was distributed. OneBlood / dba CBCF
Biologics Red Blood Cells Leukocytes Reduced W036812623250; Class II Blood product, collected fron an ineligible donor, was distributed. OneBlood / dba CBCF
Biologics Platelets Leukocytes Reduced 033FL20861; Class II Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Biologics Red Blood Cells Leukocytes Reduced 033FL20861; 033FS00741; Class II Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Biologics Platelets Pooled Leukocytes Reduced 033Z08175; Class II Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Food New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc., Hendersonville, NC 1-800-544-0777 www.newsun.net Product No. 78-1 07332 and 07183 Class II Positive E.coli New Sun Inc
Food New Sun Immune 101, Dietary Supplement 360 Capsule bottles and 100 capsule bottles, New Sun, Inc, Hendersonville NC 28792 1-800-544-0777 www.newsun.net product No. 74-0 07237 and 07238 Class II Positive E.coli New Sun Inc
Devices ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. 22288218, 22296218, 222907218 Class II Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. 22289218, 22297218, 22535218 Class II Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. 22298218 Class II Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Siemens Healthcare Diagnostics, Inc
Devices ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. 22299218 Class II Calibration failures and/or significant negative shifts in quality control (QC) and patient results. Siemens Healthcare Diagnostics, Inc
Devices HemoCue® Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. Model #, 110705, Lot #, 1207767, 1208500; 1208501; 1208772; 1208773; 1208775; 1208777-1208781; 1208787; 1208788; 1208794; 1208795; 1209513-1209517; 1209527-1209531; 1209539; 1209540; 1209546; 1209547; 1210550; 1210551; 1210556-1210558; 1210560; 1210570-1210574; 1210581-1210583; 1210587; 1210590; 1210591; 1211599; 1211602-1211605; 1211608; 1211611; 1211614; 1211616; 1211618; 1211621; 1211623; 1211626; 1211627; 1211635; 1211636; 1211646-1212649; 1212654; 1212655; 1212659; 1212676-1212680; 1212687-1212689;  ...
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Class II During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches. HemoCue AB
Drugs SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01242013@11 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01242013@5 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03112013@9, 05242013@17, 05312013@7, 06052013@21 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07222013@15, 04192013@5, 06272013@26, 07012013@5 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04172013@15, 06042013@17 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04302013@22, 02132013@8, 04122013@27, 06262013@28 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03252013@20, 04152013@11, 05232013@25, 06052013@32, 07022013@24 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07182013@1, 03202013@19, 01022013@31, 01292013@2, 04182013@10, 06142013@1, 07122013@1, 07132013@9 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03082013@20, 07032013@15 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02082013@9, 06102013@16 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06262013@33 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02202013@9 and 04052013@2 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01112013@18, 02112013@8, 03052013@11, 04032013@19, 04122013@34, 05132013@18, 06052013@37, 06212013@14 and 06292013@7 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04252013@12 and 07232013@25 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02112013@14 and 04102013@25 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01082013@7 and 05062013@29 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01212013@8, 04042013@15 and 06272013@29 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06252013@14 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02082013@12 06072013@22 06152013@1 07252013@13 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01092013@13 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03202013@33 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07232013@28 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03262013@3, 04302013@21, 06132013@1, 07102013@22 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04222013@23 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03202013@31 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. Beacon Hill Medical Pharmacy, P.C.
Drugs BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07232013@23 and 04232013@27 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01242013@2, 04172013@8, 05242013@7, 07152013@9 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02042013@22, 04102013@23, 05072013@18, 05312013@23, 07242013@3 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01152013@5, 04242013@32 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04042013@23 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01092013@12, 02132013@17, 03122013@21, 04122013@33, 05132013@17 05282013@26, 06052013@33, 06252013@4, 06272013@2, 07152013@41 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01162013@13, 05202013@23, 07112013@11 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06262013@42 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05202013@11, 07092013@19 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07162013@16 and 02262013@9 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03152013@19, 07012013@9 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05302013@6, 02112013@5, 04192013@21, 05032013@14, 01252013@11, 03272013@17, 01252013@8, 03272013@22, 01312013@9, 06062013@24, 01032013@1, 01152013@14, 01292013@4, 01312013@10, 02142013@9, 03062013@10, 03112013@6, 03112013@4, 04042013@16, 04122013@18, 04302013@24, 05102013@18, 05282013@29, 06042013@18, 06282013@10, 07112013@21, 07232013@1, 07282013@1, 07282013@2, 01312013@8, 05222013@26. Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07172013@4, 01222013@14, 03072013@10, 04032013@1, 05162013@17, 06042013@30m, 07092013@17, and 07262013@2 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05012013@25, 06202013@6 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02072013@11, 04042013@14, 01312013@3, 01072013@8 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05022013@21 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02042013@21, 02262013@3, 07242013@38 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03262013@11, 01212013@12, 02112013@17, 02262013@7, 03012013@17, 04102013@8, 04112013@7, 04292013@20, 05212013@4, 06042013@12, 06202013@3, 07152013@19, 07242013@14, Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01162013@14, 02132013@18 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06262013@22 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03192013@30, 02202013@6, 04042013@2, 04302013@20, 04252013@19 06202013@35, 06212013@17 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03202013@28, 04022013@23, 04042013@3, 06172013@25 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06132013@6 04242013@33 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03012013@16 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03072013@18, 04152013@27, 04112013@12 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 05232013@8, 06192013@26, 07102013@18, 07132013@6, 01072013@3, 02192013@10, 04172013@23, 06192013@28, 07102013@15, 07132013@8, 03232013@4, 03282013@22, 01032013@5, 01182013@24, 02052013@8, 03062013@5, 04122013@4, 04232013@26, 05132013@15, 05232013@5, 06182013@31, 06212013@12, 07132013@4, 03282013@27, 01032013@3, 01242013@16, 02192013@7, 03062013@2, 04122013@8, 04232013@29, 05232013@10, 06112013@28, 06182013@36, and 06242013@21. Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03262013@26 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05312013@24, 04242013@34 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01042013@16, 02262013@21, 03072013@9, 03042013@23, 07022013@36 07252013@18 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05032013@4, 05222013@13 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03202013@25 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02282013@12 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02262013@10, 03062013@29, 06252013@17, 07092013@18, 05092013@14 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03192013@28, 02082013@20, 04042013@10 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06272013@25, 04152013@26, 06262013@19 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01212013@10, 03042013@26, 04032013@23, 04222013@26, 06052013@12, 06122013@27, 07032013@7, 07092013@21, 07152013@40, 07262013@21 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01082013@14, 02182013@5, and 06052013@29 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04222013@14, 06052013@35, 07242013@8, 07242013@13, 04082013@11, 04292013@13, 02272013@9, 05212013@39, 03272013@28, 07032013@16, 02272013@8 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03192013@22, 03192013@24, 02132013@2 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02142013@6, 05022013@15, 07192013@13 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03192013@29, 01242013@28, 05212013@23, 06252013@1 and 07022013@27 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 02082013@10 and 07162013@10 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03282013@8, 02282013@2, 04012013@22, 05022013@22, 05012013@38 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07262013@14 and 07262013@12 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03272013@20, 02272013@17, 03262013@21, 03302013@1, 01152013@12, 02182013@10, 03112013@13, 05062013@13, 05242013@13, 05242013@12, 07012013@32 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03212013@12, 01112013@20, 03072013@19, and 05082013@27 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04012013@21, 07252013@15 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07082013@26 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05072013@26 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 06132013@30, 06272013@27 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05012013@23, 06202013@20 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 01072013@10, 02262013@5, 06272013@28 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 05202013@20 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03262013@2, 06252013@16 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 07162013@27 06262013@38 07102013@27 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03282013@4 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03182013@6, 03282013@26,01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, 03182013@14 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 03262013@5, 01212013@6, 01232013@5 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Drugs SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI 04152013@28 Class II Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Beacon Hill Medical Pharmacy, P.C.
Devices Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use. Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225 Class II TempaDot products may have been mislabeled. Medical Indicators, Inc.
Drugs K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409 Lot Number 21230-2, Exp. DEC 2015 Class II LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets. Qualitest Pharmaceuticals
Drugs EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg), POTASSIUM BICARBONATE AND POTASSIUM CHLORIDE EFFERVESCENT TABLETS FOR ORAL SOLUTION, USP, FRUIT PUNCH FLAVOR, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409 Lot Number 21230-2, Exp. DEC 2015 Class II LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets. Qualitest Pharmaceuticals
Devices STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Lot/Batch Numbers: 10104001070010*JABIL 10104001070012*JABIL 10104001070037*JABIL 10104001070038*JABIL 10104001070039*JABIL 10104001070040*JABIL 10104001070041*JABIL 10104001080027*JABIL 10104001080020*JABIL 10104001080025*JABIL 10104001080026*JABIL 10104001080028*JABIL 10104001080029*JABIL 10104001080030*JABIL 10104001080031*JABIL 10104001080033*JABIL 10104001080035*JABIL 10104001080034*JABIL 10104001080036*JABIL 10104001080037*JABIL 10104001080095*JABIL 10104001080087*JABIL 10104001080092*JABIL 10104001080090*JABIL 10104001080017*JABIL 10104001080019*JABIL 10104001080088*JABIL 10104001080039*JABIL 10104001080038*JABIL 10104001080041*JABIL 10104001080042*JABIL 10104001080069* 10104001080043*JABIL 10104001080046*JABIL 10104001080085* 10104001080086* 10104001080059* 10104001080060*JABIL 10104001080061* 10104001080063*JABIL 10104001080065*JABIL 10104001080062*JABIL 10104001080048*JABIL 10104001080049*JABIL 10104001080047*JABIL 10104001080050*JABIL 10104001080051*JABIL 10104001080053*JABIL  ...
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Class II The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15 month shelf life. Advanced Sterilization Products
Devices OPERON D850 Surgical Table Product Usage: Surgical Table 3501110-S10023, 3501110-S10024, 3501110-S10025, 3501110-S10205, 3501110-S10208, 3501110-S10064, 3501110-S10036, 3501110-S10043, 3501110-S10045, 3501110-S10050, 3501110-S10061, 3501110-S10062, 3511110-S10139, 3511110-S10143, 3511110-S10144, 3511110-S10162, 3501110-S10192, 3501110-S10018, 3511110-S10038, 3511110-S10041, 3511110-S10047, 3511110-S10072, 3511110-S10137, 3511110-S10138, 3501110-S10153, 3501110-S10166, 3501110-S10093, 3501110-S10104, 3501110-S10090, 3501110-S10147, 3501110-S10262, 3501110-S10281, 3501110-S10105, 3501110-S10172, 3501110-S10195, 3501110-S10109, 3501110-S10134, 3501110-S10099, 3501110-S10101, 3501110-S10151, 3511110-S10086, 3511110-S10092, 3511110-S10085, 3511110-S10091, 3501110-S10065, 3501110-S10037, 3501110-S10056, 3501110-S10259, 3501110-S10083, 3501110-S10170,  ...
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Class II Table was not lowering. Berchtold Corp.
Devices StaXx® IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients. Lot Numbers: 272L08 and 272L09 Class II A component Superior endplate manufactured from a different polymer than specified Spine Wave, Inc.
Devices Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold. Part Numbers: X1107-9001-000, X1107-9002-000, X1107-9003-000, X1107-9004-000, X1107-9005-000, X1107-9006-000, X1107-9007-000, X1109-9008-000, X1109-9009-000, X1107-9010-000, X1107-9011-000, X1107-9012-000, X1107-9014-000, X1107-9015-000, X1107-9016-000, X1107-9101-000, X1107-9102-000, X1107-9103-000, X1107-9201-000, X1107-9202-000, X1107-9203-000, X1107-9205-000, X1107-9206-000, X1107-9601-000, X1107-9602-000, X1107-9603-000, X1107-9604-000, X1107-9605-000, X1107-9606-000, X1107-9607-000, X1107-9608-000, X1107-9609-000, X1107-9610-000, X1107-9611-000, X1107-9612-000, X1107-9614-000, X1107-9615-000, X1107-9616-000, X1107-9617-000, M1145610-X, M1220023-X, M1220854-X, M1221495-X, 2064455-X, M1243207-X, X1107-9701-000, X1107-9702-000, X1107-9703-000,  ...
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Class II GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check, low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check, low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected, it will result in fresh gas leaking to the atmosphere and a reduction in fresh gas delivered to the breathing system. A fresh gas leak in the vaporizer does not affect delivery of the set anesthetic agent concentration but could result in a reduction in the volume of fresh gas(es) delivered to the breathing system. GE Healthcare, LLC
Devices Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N 13A0094 13B0364 13C0514 Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Devices Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Lot Numbers: 13A0084N 13D0824N Class II Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Covidien LLC
Food Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA. lot # PB0091512, exp. date 8/2014, UPC code 283333900111 Class I The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label. Reaction Nutrition LLC
Devices "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. 595531157 Class II The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration. Edwards Lifesciences, LLC
Devices Outlook Safety Infusion System Burette Set. For intravenous fluid administration. Catelog Number 375038, Lot Number 0061317318, Expiration Date: 04/30/2016 Class II Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down. B. Braun Medical, Inc.
Devices BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood. REF # 368101 Lot #3116007 Class I Exempt Device listing Number E158602 Class II The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. Becton Dickinson & Company
Devices KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas® HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas® HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas® HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas® HPV Test include the following liquid based collection media and collection device: " ThinPrep® Pap TestTM PreservCyt® Solution " Endocervical Brush/Spatula US-IVD: Material number 05232880190 Lot Number R13814, R15785 CE-IVD: Material Number: 05235898190 05235898190 05235901190 05235910190 Lot Number R15771, R15304 Class II During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas® 4800 HPV Master Mix reagent that was packaged in four (4) cobas® 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the final volume adjustment of the bulk material. This resulted in the Master Mix reagent being brought up to a lower volume than intended; as a result, the concentration of every component in the Master Mix was high by 12.7% on average. Roche Molecular Systems, Inc.
Devices Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization. Product Code - HP-SG3 Product Code -HP-PRL5 Class II Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. Cardiogenesis Corporation
Devices Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1025-106; Catalog Number -10444745; Lot code/expiration date: 2012-12-05, 2012-12-05; 2013-01-16, 2013-01-16; 2013-02-28, 2013-02-28; 2014-01-11, 2014-01-11; 2014-02-11, 2014-02-11; 2014-05-21, 2014-05-21. Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1025-108; Catalog Number - 10444747; Lot code/expiration date: 2012-06-27, 2012-06-27; 2012-08-10, 2012-08-10; 2012-10-12, 2012-10-12; 2012-11-30, 2012-11-30; 2013-01-06, 2013-01-06; 2013-02-01, 2013-02-01; 2013-03-27, 2013-03-27; 2013-10-02, 2013-10-02; 2013-11-21, 2013-11-21; 2014-01-24, 2014-01-24; 2014-03-28, 2014-03-28; 2014-05-03, 2014-05-03. Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number B1025-109, Catalog Number - 10444748 Lot code/expiration date: 2012-08-17, 2012-08-17; 2012-10-06, 2012-10-06; 2012-12-08, 2012-12-08; 2013-01-09, 2013-01-09; 2013-03-02, 2013-03-02; 2013-04-12, 2013-04-12; 2013-06-15, 2013-06-15; 2013-08-06, 2013-08-06; 2013-09-24, 2013-09-24; 2013-12-07, 2013-12-07; 2014-01-08, 2014-01-08; 2014-01-31, 2014-01-31; 2014-03-25, 2014-03-25; 2014-05-09, 2014-05-09; 2014-07-01, 2014-07-01. Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1025-112 Catalog Number - 10444749 Lot code/expiration date: 2012-07-12, 2012-07-12; 2012-10-03, 2012-10-03; 2013-06-08, 2013-06-08; 2013-12-17, 2013-12-17; 2014-04-22, 2014-04-22; 2014-06-11, 2014-06-11; Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1025-115; Catalog Number - 10483101 Lot code/expiration date: 2012-09-22, 2012-09-22; 2013-01-20, 2013-01-20; 2013-05-07, 2013-05-07; 2013-11-01, 2013-11-01; 2014-03-05, 2014-03-05. Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1016-201; Catalog Number - 10444600 Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1016-202; Catalog Number - 10444601 Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - B1016-203; Catalog Number - 10460272 Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - J1025-311; Catalog Number - 10444792 Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - J1025-312; Catalog Number - 10444793 Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan® Synergies plus® Panels & MicroScan® Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Internal Number - J1025-333; Catalog Number - 10444794 Class I Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System. Siemens Healthcare Diagnostics, Inc.
Devices Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer. Lot or Serial No. 785518 Class II Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date. Baxa Corporation
Drugs Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA Lot #06132013@1, Exp 12/10/2013 Class II Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance. South Coast Specialty Compounding, Inc.
Drugs Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA Lot #05212013@20 and Lot#03212013@6, Exp 11/17/2013 Class II Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance. South Coast Specialty Compounding, Inc.
Drugs Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA Lot #05072013@1, Exp 11/3/2013 Class II Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance. South Coast Specialty Compounding, Inc.
Drugs Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070. Lot #: 20130715@12, Exp10/13/2013 Class II Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory. Creative Compounds
Drugs Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ. Lot # 214490.00, Exp 11/29/2013 Class II Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility. Pharmacy Creations
Drugs EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869 Lot # 070213Z, Exp 1/2/2014 Class II Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility. Pharmacy Creations
Food First Street Coffee Cake Muffins (S 45398) 4 count 14 oz. UPC 0 4151210848 8 Lot# 12310,12315, 12320,1321, 12335, 12344,12348,12349,12349, 12361,13007, 13007, 13007, 13029,13032, 13032, 13035, 13036, 13053, 13063, 13065, 13066, 13099, 13114, 13123, 13124, 13133, 13134, 13136, 13137, 13141, 13142, 13142, 13151, 13155, 13162, 13162, 13171, 13176, 13177, 13182, 13186, 13187, 13193, 13196, 13203, 13207, 13210, 13217, 13227, 13222, 13229. Class I Bubbles Baking Co. is recalling coffee cake muffins because it may contain undeclared pecan nuts. KDK Management, Inc., dba Bubbles Baking Co.
Devices AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic. The AOA Mini RPE Screw Assembly is a component used in customized palate expander appliances assembled by prescription. The affected assembly may be found in products listed in the table below: Product Description: Herbst Bite Jumper Herbst Appliance Acrylic Splint M.A.R.A. (Mandibular Anterior Reposi tioning Appliance) Rapid Palatal Expander Lower Expander DeLuke Bonded Frameless Expander Haas Expander AOA Mini Rapid Palatal  ...
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Class II The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly. Sybron Dental Specialties
Devices *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity. *** 1) Product Code: 4341B; Lots: 554361 (Expires 11/30/15); 550463 (Expires 11/30/15); 548675 (Expires 11/30/15); 545891 (Expires 10/31/15); 544746 (Expires 10/31/15); 543978 (Expires 10/31/15); 542297 (Expires 10/31/15); 541063 (Expires 10/31/15); 539859 (Expires 10/31/15); 539470 (Expires 10/31/15); 537723 (Expires 9/30/15); 536497 (Expires 9/30/15); 535600 (Expires 9/30/15); 534616 (Expires 9/30/15); 532917 (Expires  ...
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Class II Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications. Carefusion 2200 Inc
Food Stonyfield Organic O Soy Yogurt Strawberry , 6 oz.cup, Refrigerated USPC code: 05215900603 Use By:11/08/2013 Class II Coliform level exceeds product specification Stonyfield Farm
Devices Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. Model: GA-0025020 Class II Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. Lumenis, Inc.
Drugs Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30 Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01 Class II Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. Hospira Inc.
Devices Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices. Lot Number 112911: 8 MM Vector TAS Screw, Part Number 601-0021 Lot Number 112911: Vector TAS Starter Kit (10 Patient), Part Number 601-0010 Class II Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces. Ormco/Sybronendo
Drugs Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 Lot# 130605@52, Exp. 12/2/2013 Class II The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Wellness Pharmacy, Inc.
Drugs Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 Lot# 130613@38, Use By: 12/10/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Wellness Pharmacy, Inc.
Drugs Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627 Lot# 130612@49, Use By: 12/9/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Wellness Pharmacy, Inc.
Drugs NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627 Lot# 130621@28, Use by: 10/19/2013 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Wellness Pharmacy, Inc.
Drugs RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627 Lot# 130710@27, Use By: 1/6/2014 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Wellness Pharmacy, Inc.
Drugs Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627 Lot# 130605@52, Exp. 12/2/13 Class II Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Wellness Pharmacy, Inc.
Drugs Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. Lot 511017, Exp 11/30/2013 Class II Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. University Compounding Pharmacy
Drugs Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. Lot #s: 474323, Exp 9/13/2013; 498616, Exp 9/25/2013; 475475, Exp 9/26/2013. Class II Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. University Compounding Pharmacy
Drugs Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. Lot 513593, Exp11/30/2013 Class II Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. University Compounding Pharmacy
Drugs PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800. Lot #: 497940, Exp 9/6/2013 Class II Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. University Compounding Pharmacy
Drugs PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800. Lot #: 497930, 11/5/2013 Class II Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns. University Compounding Pharmacy
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