The Recall Desk

Archive

July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical
82
Severe
382
High
263
Moderate
177
Low
17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 41% are Severe.

Which agencies issued them

501–600 of 921

  • HighFDA (Devices)·Z-2184-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1684-2016·2016-07-20

    Seasoned Flour Recalled for Potential Peanut Protein Presence

    Magic Seasoning Blends, LLC is recalling Taste Bud's Seasoned Flour due to potential peanut protein contamination in certain lots.

    Product
    TASTE BUDS SEASONED FLOUR, ITEM# ZEAON1040, NET WT. 40 LBS.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1679-2016·2016-07-20

    Magic Seasoning Blends Recalls Onion Breader for Potential Peanut Presence

    Magic Seasoning Blends is recalling 9,900 lbs of Onion Breader due to potential peanut protein in the milled flour used in the blend.

    Product
    ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMONS, TAMPA, FL 33609
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2016·2016-07-20

    Devicor Mammotome Biopsy System Recalled for Incorrect Needle Packaging

    Devicor Medical Products is recalling Mammotome Revolve biopsy systems because 10-gauge needles were shipped in 8-gauge packages.

    Product
    Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number a
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1678-2016·2016-07-20

    Baked in the Sun Recalls Smore's Muffins for Undeclared Peanut Residual

    Baked in the Sun Corporation is recalling Smore's Muffins because they may contain undeclared peanut residual. The product is a wholesale food service item distributed in California and Nevada.

    Product
    Baked in the Sun 4 Pack Smore's Muffin, Wholesale item (food service), not labeled for individual retail sale. 4 pcs/carton
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1250-2016·2016-07-20

    Medaus Recalls Zinc Chloride Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Zinc Chloride vials because the company cannot guarantee the product is sterile.

    Product
    ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1196-2016·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of L-Carnitine 250mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    L-CARNITINE 250MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.

    Product
    Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2016·2016-07-20

    Varian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes

    Varian Medical Systems is recalling Optical Surface Monitoring Systems (OSMS) used with TrueBeam EDGE because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automaticall
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have compromised the sutures, leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2168-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M0035431510 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2176-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.

    Product
    Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-072016·2016-07-20

    USDA Issues Public Health Alert for Kapowsin Meats Whole Hog Roasters

    USDA FSIS issued a public health alert for Kapowsin Meats whole hog roasters due to a possible link with a Salmonella outbreak in Washington.

    Product
    FSIS Issues Public Health Alert For Pork Product Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1236-2016·2016-07-20

    Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot ensure the product is sterile.

    Product
    PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules, 60 mg, because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1346-2016·2016-07-20

    ChingChunBao Anti-Aging Tablets Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling ChingChunBao Anti-Aging Tablets because they bear drug claims without an approved NDA or ANDA.

    Product
    ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, UPC 0 49987 01144 9, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2202-2016·2016-07-20

    Arrow Femoral Arterial Line Catheterization Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 50 units of Femoral Arterial Line Catheterization Kits due to shipping carton labeling errors.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2199-2016·2016-07-20

    Synthes 1.1mm Drill Bit Recalled for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 19 units of 1.1mm Drill Bits because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2016·2016-07-20

    Synthes Recalls 34 Stardrive Screwdrivers for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 34 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2016·2016-07-20

    Arrow Recalls Femoral Arterial Catheterization Kits Due to Labeling Error

    Arrow International Inc is recalling 50 femoral arterial catheterization kits because some shipping cartons contained the wrong product model.

    Product
    Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2194-2016·2016-07-20

    Synthes Recalls 1.3mm Stardrive Screwdrivers for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 75 units of 1.3mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2196-2016·2016-07-20

    Synthes Recalls 1.5mm Stardrive Screwdrivers for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 383 units of 1.5mm Stardrive Screwdrivers because their MR Safety information does not meet current ASTM standards.

    Product
    Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2154-2016·2016-07-20

    Synthes Recalls 7.0 mm and 7.3 mm Cannulated Screws for Labeling Errors

    Synthes (USA) Products LLC is recalling 7.0 mm and 7.3 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2016·2016-07-20

    Merge Healthcare Recalls OfficePACS Software Due to Data Loss Risk

    Merge Healthcare is recalling OfficePACS software versions 4.0 through 4.2 because a defect in the archiving function may cause potential data loss.

    Product
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2016·2016-07-20

    Synthes 6.5 mm Cancellous Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6.5 mm Cancellous Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2016·2016-07-20

    Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1355-2016·2016-07-20

    Murray International Trading Recalls Farser Kai Yeung Pill for Unapproved Drug Claims

    Murray International Trading Co., Inc. is recalling Farser Kai Yeung Pill because it is marketed with drug claims without FDA approval.

    Product
    FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1345-2016·2016-07-20

    Murray International Recalls Unapproved Facial Pigmentation Pills

    Murray International Trading Co. is recalling 84 bottles of facial pigmentation pills marketed without FDA approval. The products bear drug claims but are labeled as dietary supplements.

    Product
    PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a box, Kwang Chow Pharm. Ind. Corp., remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1351-2016·2016-07-20

    FDA Recalls Laryngitis Pills Marketed Without Approval

    Murray International Trading Co. is recalling Laryngitis Pills Herbal Supplement because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chin
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2191-2016·2016-07-20

    Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1352-2016·2016-07-20

    Peking Niu-Huang Chieh-Tu-Pien Tablets Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Peking Niu-Huang Chieh-Tu-Pien Tablets because they bear drug claims without FDA approval.

    Product
    PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2197-2016·2016-07-20

    Synthes Recalls 2.0mm Stardrive Screwdrivers for MR Safety Labeling Errors

    Synthes (USA) Products LLC is recalling 79 units of 2.0mm Stardrive Screwdrivers because their MR Safety labeling does not meet current ASTM standards.

    Product
    Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1354-2016·2016-07-20

    Wupooser Kai Yeung Pill Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Wupooser Kai Yeung Pill because it is marketed with drug claims without FDA approval.

    Product
    WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2190-2016·2016-07-20

    Synthes Recalls Neuro Screwdriver Blades for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 26 neuro screwdriver blades because their MR safety labels do not meet current ASTM standards.

    Product
    Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2016·2016-07-20

    Synthes Low Profile Neuro Screwdriver Blade Recalled for MR Safety Labeling

    Synthes (USA) Products LLC is recalling 50 units of Low Profile Neuro Screwdriver Blades because the MR Safety information etched or labeled on the devices does not meet current ASTM standards.

    Product
    Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1357-2016·2016-07-20

    FDA Recalls Te Xiao BaiNeiTing Herbal Supplement for Unapproved Drug Claims

    Murray International Trading Co. is recalling 17 boxes of Te Xiao BaiNeiTing Herbal Supplement because the product is marketed with drug claims without an approved NDA or ANDA.

    Product
    Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd, Imported by Murray Int'l Trading Co., Inc. New York, NY 10013, UPC 7 67533 86115 6, remaining labeling
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2016·2016-07-20

    Synthes 6.5 mm Cannulated Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2198-2016·2016-07-20

    Synthes Recalls 2.0mm Stardrive Screwdriver for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 36 units of 2.0mm Stardrive Screwdrivers because their MR safety labeling does not meet current ASTM standards.

    Product
    Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2157-2016·2016-07-20

    Synthes Recalls 4.5 mm Cannulated Screws Due to Labeling Errors

    Synthes (USA) Products LLC is recalling 4.5 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1356-2016·2016-07-20

    Ping On Ointment Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Ping On Ointment because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8gm containers within a box, PING ON OINTMENT CO LTD, PING ON OINTMENT INTERNATIONAL LTD, 149 Queen's Road West, Hong Kong, UPC 8 33679 00001 5, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2016·2016-07-20

    Merge OfficePACS Software Recalled for Potential Data Loss

    Merge Healthcare is recalling OfficePACS software version 3.4 because archiving failures may cause data loss at 49 medical facilities.

    Product
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-1439-2016·2016-07-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 2,088 boxes of Daytrana transdermal patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2016·2016-07-20

    Synthes 4.5 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.5 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1353-2016·2016-07-20

    Gastrodia Capsules Recalled for Unapproved Drug Claims

    Murray International Trading Co. is recalling Gastrodia Capsules because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1358-2016·2016-07-20

    Murray International Recalls Unapproved Flucinonide Ointment Cream

    Murray International Trading Co., Inc. is recalling 97 boxes of FUQINGSONG RELIEF CREAM because it is marketed as a dietary supplement but bears drug claims, making it an unapproved drug.

    Product
    FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST: 96 BAWAEI ROAD, HEDONG COUNTY, TIANJIN CITY, remaining labeling contains Chine
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1440-2016·2016-07-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling specific lots of Daytrana transdermal patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2193-2016·2016-07-20

    Synthes Recalls Surgical Handles for Incorrect MR Safety Labeling

    Synthes (USA) Products LLC is recalling 29 surgical handles because their MR safety labels do not meet current ASTM standards.

    Product
    Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1350-2016·2016-07-20

    Murray International Recalls Tien Ma Tou Tong Wan Pills for Unapproved Drug Claims

    Murray International Trading Co. is recalling Tien Ma Tou Tong Wan pills because they bear drug claims despite being marketed as dietary supplements.

    Product
    Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2158-2016·2016-07-20

    Synthes Recalls 3.5 mm and 4.0 mm Cannulated Screws for Labeling Errors

    Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1438-2016·2016-07-20

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 7,850 boxes of Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2016·2016-07-20

    Synthes 4.0 mm Cortex Screw Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 4.0 mm Cortex Screws because the labeling does not match the cleared indications for use in the United States and Canada.

    Product
    4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Dissolution Failure

    Apotex Scientific is recalling Duloxetine Delayed-Release Capsules because stability testing revealed out-of-specification dissolution results.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2145-2016·2016-07-20

    Ortho VITROS AFP Reagent Pack Recall Due to Calibration Failure

    Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.

    Product
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2016·2016-07-20

    West-Ward Recalls Oxycodone Hydrochloride Oral Solution for Impurity Failures

    West-Ward Columbus Inc. is recalling 1,182 bottles of Oxycodone Hydrochloride Oral Solution due to failed impurities and degradation specifications.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2143-2016·2016-07-20

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 30 enGen Laboratory Automation Systems due to a software error that displays incorrect interpretive text for certain test results.

    Product
    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2203-2016·2016-07-20

    Roche Recalls Influenza Quality Control Kits Due to Incorrect Expiration Dates

    Roche Molecular Systems is recalling 194 cobas Liat Influenza A/B Quality Control Kits because they are labeled with incorrect expiration dates.

    Product
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Drugs)·D-1435-2016·2016-07-20

    Apotex Recalls Duloxetine Capsules Due to Failed Dissolution Testing

    Apotex Scientific is recalling specific lots of Duloxetine Delayed-Release Capsules because they failed dissolution specifications during stability testing.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2148-2016·2016-07-20

    Breathe Right Clear Nasal Strips Recalled for Incorrect Packaging Labels

    GSK Consumer Healthcare is recalling Breathe Right Clear nasal strips because some secondary packaging cartons were incorrectly labeled for the AU/NZ market.

    Product
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V537000·2016-07-19

    Spartan Motors Recalls Transit Bus Chassis Cabs Due to Frame Cracks

    Spartan Motors is recalling 2011-2015 Transit Bus Chassis Cabs because frames may crack, potentially reducing driver control and increasing crash risk.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V540000·2016-07-19

    BMW Recalls 2015 M5 and M6 Models for Driveshaft Weld Defect

    BMW is recalling 956 model year 2015 M5 and M6 vehicles because a defective driveshaft weld may cause loss of propulsion or vehicle rolling, increasing crash risk.

    Product
    BMW — BMW M5, M6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V543000·2016-07-19

    Blue Bird Vision Transit Buses Recalled for Propane Fuel Line Defect

    Blue Bird is recalling 2016-2017 Vision transit buses with 6.8L Ford engines and Gen 3 propane units because fuel lines may rub, causing leaks and fire risk.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V541000·2016-07-19

    Ditch Witch T14MV Trailer Recalled for Brake Wiring Defect

    Charles Machine Works is recalling 2016 Ditch Witch T14MV trailers because an incorrect wiring harness may prevent brakes from applying if the trailer separates from the tow vehicle.

    Product
    DITCH WITCH — DITCH WITCH T14MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16227·2016-07-19

    GSI Outdoors Recalls Children's Water Bottles for Lead Violation

    GSI Outdoors is recalling about 6,700 children's insulated water bottles sold at L.L.Bean because lead solder at the base violates safety standards.

    Product
    Kids' insulated water bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·061-2016·2016-07-19

    Bar-S Foods Recalls Chicken and Pork Hot Dogs Due to Listeria Risk

    Bar-S Foods is recalling approximately 372,684 pounds of chicken and pork hot dog and corn dog products due to possible Listeria monocytogenes contamination.

    Product
    Bar-S Foods Company — Bar-S Foods Company Recalls Chicken and Pork Hot Dog and Corn Dog Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·16228·2016-07-19

    Things Remembered Recalls Children's Jewelry Due to Lead Violation

    Things Remembered is recalling silver bracelets and charm necklaces for children because the clear surface coating contains lead in excess of allowable limits.

    Product
    Silver bracelets and charm necklaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V538000·2016-07-19

    Starcraft RV Recalls AR-ONE Maxx Trailers for Incorrect Tire Labeling

    Starcraft RV is recalling 2016-2017 AR-ONE Maxx travel trailers and fifth wheels because incorrect tire labels may lead to improper tire replacement.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AR-ONE MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·056-2016 EXP·2016-07-15

    ConAgra Recalls Frozen Chicken and Beef Entrées Due to Metal Contamination

    ConAgra Foods is recalling approximately 195,597 pounds of frozen P.F. Chang's Home Menu chicken and beef products due to potential metal contamination. No injuries have been reported.

    Product
    Conagra Brands (Conagra Foods Packaged Foods, LLC) — ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·16757·2016-07-15

    Nestlé AccuPure Water Dispensers Recalled for Fire and Burn Hazards

    Nestlé Waters North America is recalling AccuPure countertop water dispensers because they can overheat, melt, and smoke, posing fire and burn risks.

    Product
    AccuPure countertop filtered water dispensers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·16223·2016-07-14

    Flushmate III Pressure-Assist Flushing Systems Recalled for Bursting Hazard

    Flushmate is recalling about 453,000 Flushmate III Pressure-Assist Flushing Systems in the U.S. because the units can burst, posing impact and laceration hazards.

    Product
    Flushmate® III Pressure-Assist Flushing Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V536000·2016-07-14

    Altec Recalls 2015-2016 Aerial Devices and Digger Derricks for Winch Defect

    Altec is recalling 252 model year 2015-2016 Aerial Devices and Digger Derricks because a hydraulic motor shaft may fail, causing unexpected winch movement and increasing injury risk.

    Product
    ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16225·2016-07-14

    Liquid Plumr Clog Removers Recalled for Non-Child-Resistant Caps

    The Clorox Company is recalling three Liquid Plumr clog remover products because the bottles lack required child-resistant closures, posing a risk of chemical burns.

    Product
    Liquid Plumr® Pro-Strength Foaming Clog Fighter®, Liquid Plumr® Industrial Strength Urgent Clear® and Liquid Plumr® Pro-Strength Urgent Clear® clog removers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16226·2016-07-14

    IKEA Recalls Safety Gates and Extensions Due to Fall Hazard

    IKEA is recalling PATRULL safety gates and extensions because the locking mechanism can open unexpectedly, posing a fall hazard to children.

    Product
    Safety gates and safety gate extensions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16224·2016-07-14

    Home Source Recalls Floor Lamps Due to Fire and Shock Hazards

    Home Source is recalling about 2,700 floor lamps sold in the New York area and online because defective sockets can cause fires and electric shocks.

    Product
    Floor lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·060-2016·2016-07-14

    Haring Catfish Recalls Catfish Products Due to Gentian Violet Residue

    Haring Catfish, Inc. is recalling approximately 21,521 pounds of catfish products found to contain gentian violet, a chemical residue of public health concern.

    Product
    Haring Catfish — Haring Catfish, Inc. Recalls Siluriformes Fish Products Due To Possible Adulteration
    Category
    Food
    Distribution
    6 states
  • ModerateUSDA FSIS·052-2016 EXP-2·2016-07-14

    U.S. Cado Holdings Recalls Imported Frozen Swai Fillets for Regulatory Non-Compliance

    U.S. Cado Holdings is recalling approximately 29,645 pounds of imported frozen Swai fillets that entered U.S. commerce without meeting federal residue testing requirements.

    Product
    U.S. Cado Holdings, Inc. Recalls Imported Siluriformes Fish Products Distributed Without Meeting FSIS Requirements
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Drugs)·D-1148-2016·2016-07-13

    FDA Recalls Ultimate Formula Capsules Tainted With Undeclared Sibutramine

    Bee Extremely Amazed LLC is recalling Ultimate Formula Capsules because they contain undeclared sibutramine, a withdrawn drug.

    Product
    Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1624-2016·2016-07-13

    Wegmans Brownie with Icing Recalled for Undeclared Milk Allergen

    Wegmans Food Markets is recalling 16 oz. Brownie with Icing pans due to an undeclared milk allergen. The product was distributed in six states.

    Product
    Wegmans Brownie with Icing, Pan, 16 oz., UPC#7789082502
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1656-2016·2016-07-13

    Kroger Cajun Style Mirepoix Blend Recalled for Listeria Risk

    The Pictsweet Company is recalling Kroger Cajun Style Mirepoix Blend due to possible Listeria monocytogenes contamination in the onions.

    Product
    Kroger(R) CAJUN STYLE MIREPOIX BLEND, onions, celery, and green bell peppers, RECIPE BEGINNINGS(R), NET WT 12 OZ (340g), UPC 11110 89787, DISTRIBUTED BY THE KROGER COMPANY, CINCINNATI, OH 45202
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1139-2016·2016-07-13

    Asset extreme+PLUS Capsules Recalled for Undeclared Sibutramine

    Bee Extremely Amazed LLC is recalling Asset extreme+PLUS Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.

    Product
    Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com www.allnaturalbeelievers.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1628-2016·2016-07-13

    Way Fong Seafood Ball Combo Recalled for Undeclared Egg Allergen

    Way Fong LLC is recalling Seafood Ball Combo Assorti products due to the presence of undeclared egg allergen, posing a risk to individuals with egg allergies.

    Product
    SEAFOOD BALL COMBO ASSORTI BOULETTES AUX PRODUCTS DE MER FISH BALL, FRIED FISH BALL, FRIED SHRIMP BALL, FISH BALL WITH DACE, CUTTLEFISH BALL, Net Wt 260g/9.2oz, UPC 0 68636 05205 2, Product of Canada, KEEP REFRIGERATED
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1144-2016·2016-07-13

    Oasis Capsules Recalled for Undeclared Sibutramine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling Oasis Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.

    Product
    Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1140-2016·2016-07-13

    Bee Pollen Capsules Recalled for Undeclared Withdrawn Drug Ingredients

    Bee Extremely Amazed LLC is recalling EVOLVE BEE POLLEN Capsules nationwide because they contain undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.

    Product
    EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1147-2016·2016-07-13

    SLIM TRIM U Capsules Recalled for Undeclared Sibutramine

    Bee Extremely Amazed LLC is recalling SLIM TRIM U Capsules because they contain undeclared sibutramine, a withdrawn drug.

    Product
    SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1142-2016·2016-07-13

    Jenesis Capsules Recalled for Undeclared Sibutramine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling Jenesis Capsules marketed as a dietary supplement because they contain undeclared sibutramine and phenolphthalein, both withdrawn from the US market for safety reasons.

    Product
    Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1145-2016·2016-07-13

    Prime Capsules Recalled for Undeclared Sibutramine and Phenolphthalein

    Bee Extremely Amazed LLC is recalling Prime Capsules because they contain undeclared sibutramine and phenolphthalein, making them unapproved drugs.

    Product
    Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1157-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling 148 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1154-2016·2016-07-13

    Cantrell Drug Recalls Subpotent Fentanyl Citrate Injection Syringes

    Cantrell Drug Company is recalling 42 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.

    Product
    fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1626-2016·2016-07-13

    Wegmans Chocolate Chip Brownie Recalled for Undeclared Milk Allergen

    Wegmans is recalling Chocolate Chip Brownies because they contain undeclared milk. Consumers should not eat the product and should return it to the store.

    Product
    Wegmans Chocolate Chip Brownie, 2 pack, UPC#7789098966
    Category
    Food
    Distribution
    6 states

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