The Recall Desk

Archive

December 2015 recalls

614 recalls were announced in December 2015.

What the numbers show

Critical
17
Severe
215
High
208
Moderate
133
Low
41

Of the 614 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

301–400 of 614

  • HighFDA (Food)·F-0350-2016·2015-12-16

    Norpac IQF Cut Wax Beans Recalled for Listeria Contamination

    Norpac Foods is recalling IQF Cut Wax Beans due to Listeria monocytogenes contamination. The product was distributed to food service accounts in seven states.

    Product
    IQF FLAV-R-PAC Cut Wax Beans, there are 12/2 lbs. bags per case. Catalog # 07570. Product was distributed to Food Service accounts. The label has Cooking Directions and Safe Handling Instructions. The UPC 0 48800 07570 5 is observed on the bag. The Item No. 100488000
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0380-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2016·2015-12-16

    Olympus ENDOEYE HD II Video Telescopes Recalled Due to Overheating Tip

    Olympus is recalling 182 ENDOEYE HD II video telescopes because a damaged temperature sensor can cause the tip to overheat, posing a burn risk to patients and users.

    Product
    Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2016·2015-12-16

    Philips Brilliance CT Scanner Software Recall for Incorrect Tumor Localization

    Philips is recalling Brilliance CT scanners with software version 2.0 because a printing error may display incorrect tumor locations, potentially leading to patient mistreatment.

    Product
    Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0375-2016·2015-12-16

    Synthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems

    Synthes (USA) Products LLC is recalling five TFN-Advanced Proximal Femoral Nailing Systems because a design defect may prevent proper locking mechanism advancement or screw tightening.

    Product
    Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0351-2016·2015-12-16

    Lakeside Foods Recalls French Style Green Beans for Listeria Risk

    Lakeside Foods is recalling 16 oz bags of French Style Green Beans due to potential Listeria monocytogenes contamination.

    Product
    French Style Green Beans packaged under the following labels: 1. Giant Eagle, Net Wt. 16 oz (1 LB) 454 g, UPC 30034-00978; 2. Shur fine, Net Wt. 16 oz, 1 LB (454 g), UPC 11161-13478
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0399-2016·2015-12-16

    Visicu eCareManager Software Recalled for Medication Order Defect

    Visicu, Inc. is recalling 43 units of eCareManager software due to a defect that may cause incorrect medication orders to be displayed and signed.

    Product
    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allo
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0343-2016·2015-12-16

    Shrimp and Imitation King Crab Tacos Recalled for Undeclared Egg Allergen

    Fabrica Confecciones Soto, Inc. is recalling Shrimp with Imitation King Crab Tacos because they contain undeclared egg whites.

    Product
    Taco de Camar¿n con Imitaci¿n de King Crab (Shrimp with Imitation King Crab Taco). Label reads in part : " *** Soto Fabrica & Confecciones"*** Tacos de Camarones*** Mantenganse Congelado"*** Peso Neto 5 lbs(2.3 kg)*** Manufacturado por: Fabrica Confecciones Soto, Inc. calle Auto
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0384-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2016·2015-12-16

    GE Revolution CT Scanners Recalled for Potential Head Scan Artifacts

    GE Medical Systems is recalling 125 Revolution CT scanners worldwide due to potential image artifacts in head scans that may mimic pathology. No injuries have been reported.

    Product
    GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmissi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0381-2016·2015-12-16

    Skipanon Brand Canned Smoked Salmon Recalled for Processing Concerns

    Skipanon Brand Seafoods is recalling canned smoked peppered Chinook salmon due to lack of documentation and possible under-processing, which could allow Clostridium botulinum contamination.

    Product
    Canned Smoked Peppered Chinook Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD Peppered SMOKED CHINOOK SALMON Ingredients: Salmon, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke***Net wt. 5 1/2 oz. (156g)***" UPC: 58071 00114 Can cod
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0389-2016·2015-12-16

    Skipanon Brand Seafood Recalled for Possible Under-Processing

    Skipanon Brand Seafoods LLC is recalling all canned and pouch seafood products due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Peppered Smoked Steelhead with paper label reading in part: ***SKIPANON BRAND SEAFOOD Peppered SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke. Net WT. 5 1/2 oz. (156g)***" UPC: 58071 00143 C
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0385-2016·2015-12-16

    Skipanon Brand Canned Smoked Salmon Recalled for Under-Processing Risk

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked Chinook salmon due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Smoked Chinook Salmon with paper label reading in part: "***SKIPANON BRAND SEAFOOD SMOKED CHINOOK SALMON***Ingredients: Salmon, Sea Salt, Brown Sugar Natural Hardwood Smoke. Net wt. 5 1/2 oz. (156g)***" UPC: 58071 00112 Can code beginning with OCC. Label has a ye
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0387-2016·2015-12-16

    Skipanon Brand Canned Smoked Sockeye Salmon Recalled for Processing Concerns

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked sockeye salmon due to lack of documentation and possible under-processing.

    Product
    Canned Smoked Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED SOCKEYE SALMON***Ingredients: Sockeye Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET wt. 5.5 oz. (170g)***" UPC: 58071 00140 Can code beginning with OCB. Label
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0390-2016·2015-12-16

    Skipanon Brand Canned Smoked Sturgeon Recalled for Processing Concerns

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked sturgeon due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Smoked Sturgeon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED STURGEON***INGREDIENTS: Sturgeon, Sea Salt, Brown Sugar Natural Hardwood Smoke. NET WT. 5.5 OZ. (156g)***" UPC: 58071 00111 Can code beginning with OCP. Label has a yellow backgrou
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0380-2016·2015-12-16

    Skipanon Brand Seafood Recalled for Potential Botulism Risk

    Skipanon Brand Seafoods LLC is recalling all cans and pouches of its seafood products due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Label reads in part "***SKIPANON BRAND SEAFOOD SMOKED ALBACORE TUNA***INGREDIENTS: Albacore Tuna, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET WT. 5.5 OZ. (156g) ***" UPC: 58071 00116 Can code beginning with OCKH. Label background is yellow with a blue strip on th
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2016·2015-12-16

    Skipanon Brand Seafood Recalled for Lack of Documentation and Processing Concerns

    Skipanon Brand Seafoods LLC is recalling all cans and pouches of its seafood products due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET WT. 5 1/2 oz. (156g)***" UPC: 58071 00142 Code beginning with "OC" Label has a ye
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0377-2016·2015-12-16

    Wegmans Dark Chocolate Pistachio Toffee Recalled for Undeclared Milk

    First Source LLC is recalling Wegmans Dark Chocolate Pistachio Toffee because it contains undeclared cream (milk). The product was sold in New York.

    Product
    Wegmans Premium Dark Chocolate Pistachio Toffee, NET WT 9 OZ (255 g), UPC 0 77890 12698 1, Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603, Product contains tan and brown labels fixed to the top and bottom of the clear plastic tubs and shipped 12 units per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0409-2016·2015-12-16

    Philips Brilliance 64 CT System Recalled for Software Defects

    Philips is recalling 1,765 Brilliance 64 CT systems worldwide due to software defects that may cause operational errors, image issues, or misdiagnosis.

    Product
    Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2016·2015-12-16

    Implant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants

    Implant Direct Sybron Manufacturing is recalling 26 lots of DirectGuide Drill Extenders because the drill may drop during use.

    Product
    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0404-2016·2015-12-16

    Sterilmed Recalls Reprocessed Tourniquet Cuffs Due to Sterility Concerns

    Sterilmed is voluntarily recalling reprocessed tourniquet cuffs because the company cannot assure the sterility of all units in the affected lots.

    Product
    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2016·2015-12-16

    Zimmer Persona EM Distal Rod Recalled for Ratchet Latching Defect

    Zimmer, Inc. is recalling 156 Persona EM Distal Rods because the ratchet teeth may not latch onto the rod. The defect could affect the stability of the surgical instrument during use.

    Product
    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0410-2016·2015-12-16

    Zimmer Persona EM Proximal Tube Recalled for Ratchet Latching Failure

    Zimmer, Inc. is recalling 156 Persona EM Proximal Tubes because the ratchet teeth may not latch onto the rod.

    Product
    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0378-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16059·2015-12-16

    Skip Hop Recalls Crib Mobiles Due to Injury Hazard

    Skip Hop is recalling Moonlight & Melodies projection crib mobiles because the strap attaching the product to the crib rail can break, posing an injury hazard if the product falls on an infant.

    Product
    Skip Hop crib mobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0386-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0346-2016·2015-12-16

    Durrset Amigos Recalls Texas Style HEB Charro Beans Due to Foreign Material

    Durrset Amigos Ltd. is recalling specific cans of Texas Style HEB Charro Beans because they may contain foreign material, including rocks.

    Product
    Texas Style HEB Charro Beans NET WT. 15 OZ (425g) in metal cans UPC: 041220927142. Texas Style HEB Charro Beans NET WT. 31 OZ (1.94 LB) 879g in metal cans UPC: 041220543692.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0520-2016·2015-12-16

    Pfizer Recalls Norpace CR Capsules for Failed Dissolution Specification

    Pfizer is recalling Norpace CR (disopyramide phosphate) capsules because they failed to meet dissolution specifications. The recall covers specific lots distributed nationwide.

    Product
    NORPACE CR — NORPACE CR (DISOPYRAMIDE PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2016·2015-12-16

    In2Bones Recalls Osteosynthesis Screws with Incorrect Torx Imprint

    In2Bones is recalling 20 units of Model S25 ST014 osteosynthesis screws distributed in Tennessee because they were manufactured with the incorrect Torx imprint on the screw head.

    Product
    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0381-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0373-2016·2015-12-16

    Thrive Foods Recalls Organic Blenditup Smoothie Mix Due to Foreign Object

    Thrive Foods LLC is recalling 5,305 canisters of Organic Blenditup Smoothie Mix because a wingnut was found inside a canister.

    Product
    Organic blenditup Protein + Plant Based Smoothie Mix, No Dairy, Vitamin Fortified, 100% Vegan, Mild Natural Flavor with a Hint of Sweetness, Net Wt. 24 oz (682g), packaged in plastic canister, 12 packages per case. Distributed by: Blenditup, 504 W. Buena Vista, Suite 1, Washingt
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0348-2016·2015-12-16

    Durrset Amigos Recalls Texas Style Borracho Beans Due to Foreign Material

    Durrset Amigos Ltd. is recalling specific cans of Texas Style HEB Borracho Beans because they may contain rocks.

    Product
    Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 15 OZ (425g) in metal cans; Texas Style HEB Borracho Beans Made with Shiner Rock NET WT. 31 OZ (1.94 LB) 879g in metal cans.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0349-2016·2015-12-16

    Saputo Recalls Chocolate Whipped Topping for Undeclared Food Colorings

    Saputo Dairy Foods USA is recalling specific lots of chocolate whipped topping due to undeclared Red #40, Yellow #5, Yellow #6, and Blue #1 food colorings.

    Product
    1.) Essential EVERYDAY Chocolate Flavored Dairy Whipped Topping, Made with Real Cream, Ultra-Pasteurized Grade A, NET WT 13 OZ (368g); 2.) HyVee Chocolate FLAVORED WHIPPED TOPPING ULTRA-PASTEURIZED GRADE A - SWEETENED, NET WT 13 OZ (368g); 3.) Lucerne DAIRY FARMS Chocolate Whippe
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0518-2016·2015-12-16

    Steris Recalls Kindest Kare Antimicrobial Foaming Handwash Due to Labeling Error

    Steris is recalling 54 bottles of Kindest Kare Antimicrobial Foaming Handwash because an outdated label incorrectly lists an inactive ingredient.

    Product
    Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0517-2016·2015-12-16

    RemedyRepack Recalls Rocuronium Bromide Vials Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling Rocuronium Bromide 50 mg/5 mL vials because the product labels contain incorrect storage instructions.

    Product
    Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2016·2015-12-16

    RemedyRepack Recalls Lorazepam Injections Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling 1,625 vials of Lorazepam 2 mg/mL injection because the product labels contain incorrect storage instructions.

    Product
    Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0316-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0373-2016·2015-12-16

    Smith & Nephew Volar Distal Radius Plates Recalled for Incorrect Marking

    Smith & Nephew is recalling 9 units of PERI-LOC VOLAR DISTAL RADIUS PLATES because they were laser marked and packaged with incorrect anatomical orientation.

    Product
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0398-2016·2015-12-16

    Edwards Thin-Flex Venous Cannula Recalled for Incorrect Connector Size Labeling

    Edwards Lifesciences is recalling Thin-Flex Venous Cannulas because the product guide incorrectly lists the connector size as 3/8 inch instead of the actual 1/2 inch.

    Product
    Thin-Flex Venous Cannula, Model Number:TF292902A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0372-2016·2015-12-16

    Smith & Nephew Recalls Anatomically Incorrect Volar Distal Radius Plates

    Smith & Nephew is recalling 9 units of PERI-LOC Volar Distal Radius Plates that were laser marked and packaged with incorrect anatomical orientation.

    Product
    Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0395-2016·2015-12-16

    Powers Medical Devices Recalls Pacifier Activated Lullaby Systems for Labeling Issues

    Powers Medical Devices is recalling 128 Pacifier Activated Lullaby (PAL) Systems because the units' labeling is inconsistent with their FDA-cleared indications.

    Product
    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2016·2015-12-16

    RemedyRepack Recalls Ascorbic Acid Injection Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling Ascorbic Acid 500 MG/ML Injection vials because they contain incorrect storage instructions on the label.

    Product
    Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0431-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2016·2015-12-16

    BioHorizons Dental Implant Recalled Due to Incorrect Length Labeling

    BioHorizons is recalling 32 units of 5.0 x 15mm dental implants because the packaging incorrectly listed the length as 10.5mm.

    Product
    RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0509-2016·2015-12-16

    Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets Due to Impurities

    Golden State Medical Supply Inc. is recalling 1,136 bottles of Meclizine Hydrochloride tablets because they failed impurity specifications.

    Product
    MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0371-2016·2015-12-16

    Valeant SPAG-2 6000 Aerosol Generator Recalled for Missing Particle Size Testing

    Valeant Pharmaceuticals is recalling 61 units of the SPAG-2 6000 aerosol generator because they were released without required particle size testing.

    Product
    Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0511-2016·2015-12-16

    RemedyRepack Recalls Humulin 70/30 Vials Due to Incorrect Storage Instructions

    RemedyRepack, Inc. is recalling 65 vials of Humulin 70/30 insulin due to incorrect storage instructions on the label.

    Product
    Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2016·2015-12-16

    RemedyRepack Recalls Bicillin L-A Due to Incorrect Storage Instructions

    RemedyRepack, Inc. is recalling 60 vials of Bicillin L-A 600,000 Units/mL injection because the product labels contain incorrect storage instructions.

    Product
    Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: RemedyRepack, Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0253-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0347-2016·2015-12-16

    Durrset Amigos Recalls Texas Style HEB Charro Beans Due to Foreign Material

    Durrset Amigos Ltd. is recalling Texas Style HEB Charro Beans Spicy in 15 oz cans because they may contain foreign material, specifically rocks.

    Product
    Texas Style HEB Charro Beans Spicy NET WT. 15 OZ (425g) in metal cans UPC: 041220927159.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0387-2016·2015-12-16

    LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2016·2015-12-16

    LeMaitre NovaSil Silicone Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 units of NovaSil Silicone Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2016·2015-12-16

    RemedyRepack Recalls Vitamin B-Complex Injections Due to Labeling Error

    RemedyRepack Inc. is recalling Vitamin B-Complex 100 injections because the vials contain incorrect storage instructions.

    Product
    Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0873-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2016·2015-12-16

    LeMaitre NovaSil Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling NovaSil Embolectomy Catheters due to a manufacturing issue that could compromise packaging sterility.

    Product
    LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2016·2015-12-16

    RemedyRepack Recalls Novolin 70/30 Vials Due to Incorrect Storage Instructions

    RemedyRepack Inc. is recalling 106 vials of Novolin 70/30 insulin because the packaging contains incorrect storage instructions.

    Product
    Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 52125-0414-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0377-2016·2015-12-16

    Windstone AMS 4675 Angio Pack Recalled Due to Component Issue

    Windstone Medical Packaging is recalling 40 kits of the AMS 4675 Angio Pack because they contain a recalled Seldinger Needle.

    Product
    AMS 4675 Angio Pack. For use in a general clinical procedure.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0510-2016·2015-12-16

    Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets for Impurities

    Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    Product
    MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0352-2016·2015-12-16

    Red Bull Total Zero Energy Drink Recalled for Missing Phenylalanine Warning

    Red Bull North America is recalling 1,395 cases of Total Zero Energy Drink because the cans are missing the mandatory phenylalanine warning for individuals with phenylketonuria.

    Product
    Red Bull Total Zero Energy Drink, 12 fl.oz. (355ml), UPC CODE(S): ON THE CAN: 6 11269 62373 4; ON THE CASE: 6 11269 61505 0
    Category
    Food
    Distribution
    16 states
  • SevereNHTSA·15V841000·2015-12-15

    Great Dane Reefer Trailers Recalled for Brake Caliper Bolt Issue

    Great Dane is recalling 2015-2016 Reefer trailers because improperly tightened caliper bolts may allow the brake caliper to detach, reducing braking performance.

    Product
    GREAT DANE — GREAT DANE REEFER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V843000·2015-12-15

    Thomas Built Buses Recalling School Buses Due to Seat Defect

    Daimler Trucks North America is recalling 2016-2017 Thomas Built Buses school buses because certain seats may tilt rearward in a severe rear-end collision.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER HDX, MINOTOUR, SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V842000·2015-12-15

    Thomas Built Buses Saf-T-Liner C2 School Bus Window Retention Recall

    Daimler Trucks North America is recalling 2016 Thomas Built Buses Saf-T-Liner C2 school buses because push-out tempered glass windows may not remain attached during a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16715·2015-12-15

    Lithonia Lighting Recalls JHBL LED Fixtures Due to Falling Risk

    Lithonia Lighting is recalling JHBL LED fixtures because the mounting hub can break, causing the fixture to fall. No injuries have been reported.

    Product
    JHBL LED Fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V838000·2015-12-14

    Charmac Recalls 2015-2016 Horse and Cargo Trailers Due to Axle Weld Failure

    Charmac is recalling 2015-2016 Horse and Cargo trailers because a weld on the torsion axle may fail, causing the wheel assembly to separate and increasing crash risk.

    Product
    CHARMAC — CHARMAC HORSE TRAILER, CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V837000·2015-12-14

    MCI Recalls 2015 Motor Coaches Due to Missing Axle Welds

    Motor Coach Industries is recalling specific 2015 D4500 and D4505 motor coaches because drive axles may be missing welds on hanger brackets, which could separate and affect vehicle control.

    Product
    MCI — MCI D4500, D4505
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V839000·2015-12-14

    Altec Recalls Manitex/PM Knuckle Boom Cranes Due to Outrigger Weld Cracks

    Altec is recalling 2013-2014 Manitex/PM Knuckle Boom Cranes because outrigger welds may crack, causing failure and increasing the risk of the truck tipping over.

    Product
    MANITEX/PM — MANITEX/PM KNUCKLE BOOM CRANES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V833000·2015-12-11

    GM Recalls 2016 Acadia, Traverse, Enclave for Seat Frame Weld Defect

    General Motors is recalling 2,633 model year 2016 Chevrolet Traverse, GMC Acadia, and Buick Enclave vehicles because the third-row left lower seat frame may have welds in incorrect locations.

    Product
    GMC — GMC, CHEVROLET, BUICK ACADIA, TRAVERSE, ENCLAVE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V835000·2015-12-11

    Trail Boss Recalls 2013 Bloomer Horse Trailer Water Heater

    Trail Boss is recalling one 2013 Bloomer Horse Trailer because a water heater valve may cause overheating, posing a scalding risk.

    Product
    BLOOMER — BLOOMER HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V836000·2015-12-11

    McLaren Recalls 2014-2015 P1 Vehicles Due to Hood Latch Defect

    McLaren is recalling 122 model year 2014-2015 P1 hybrid vehicles because the secondary hood latch may fail to re-engage, potentially allowing the hood to open while driving.

    Product
    MCLAREN — MCLAREN P1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V834000·2015-12-11

    Highland Ridge RV Recalls Fifth Wheels and Travel Trailers for Missing Label

    Highland Ridge RV is recalling specific 2015-2016 fifth wheels and travel trailers because they may be missing a caution label regarding the sewer drain valve.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW, OPEN RANGE OPEN RANGE, 3X, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16713·2015-12-10

    Polaris Recalls RZR XP Turbo Vehicles Due to Oil Leak Fire Hazard

    Polaris is recalling about 2,230 RZR XP Turbo recreational off-highway vehicles because an oil drain line leak can cause a fire.

    Product
    Recreational Off-Highway Vehicles (ROV)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V832000·2015-12-10

    Roush Recalls 2015 Ford Mustang GT Stage 3 for Brake Caliper Defect

    Roush is recalling 2015 Ford Mustang GT Roush Stage 3 vehicles because a brake caliper guide pin may loosen, reducing rear braking ability and increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V830000·2015-12-10

    GM Recalls 2016 Silverado and Sierra Trucks for Air Bag Sensor Defect

    General Motors is recalling 2016 Chevrolet Silverado and GMC Sierra trucks because a misplaced mounting stud may cause the air bag sensor housing to fracture, potentially preventing air bag deployment in a crash.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15T022000·2015-12-10

    Cooper Zeon LTZ Tires Recalled for Tread Cracking and Lug Chunking

    Cooper Tire & Rubber Co. is recalling specific Zeon LTZ tires manufactured in September 2015 because tread cracking or chunking may cause loss of tire pressure, increasing crash risk.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0329-2016·2015-12-09

    Goodcents Fresh Baked Giant Cookies Recalled for Peanut Contamination

    Mr Goodcents Inc is recalling Fresh Baked Giant Cookies due to potential peanut contamination. The product was distributed to six states.

    Product
    Goodcents deli fresh subs Fresh Baked Giant Cookie, Chocolate Chip Cookie, Serving Size: 1 Cookie, Approx. NET WT. 2.5 oz. Frozen cookie dough is manufactured by Custom Foods Inc. De Soto, KS 66018.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0417-2016·2015-12-09

    Western Drug Recalls Alcohol and Bupivicaine Solution Due to Sterility Concerns

    Western Drug is recalling Alcohol 4%/Bupivicaine 0.5% solution because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Alcohol4%/Bupivicaine0.5% sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0461-2016·2015-12-09

    Western Drug Recalls Toradol Injection Due to Sterility Concerns

    Western Drug is recalling Toradol 60mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Toradol 60mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0474-2016·2015-12-09

    Western Drug Recalls Sodium Hydroxide 10% Injection Due to Sterility Concerns

    Western Drug is recalling Sodium Hydroxide 10% Injection because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide.

    Product
    Sodium Hydroxide 10% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0415-2016·2015-12-09

    Western Drug Recalls Methylcobalamin Injection Due to Sterility Concerns

    Western Drug Inc. is recalling Methylcobalamin Injection because the product lacks assurance of sterility. The recall affects 34 containers distributed nationwide.

    Product
    Methylcobalamin Injection 10 mg/mL, 20 mg/mL, 30 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0420-2016·2015-12-09

    Western Drug Recalls Benadryl Injection Due to Sterility Concerns

    Western Drug is recalling Benadryl 50mg/2mL Pres-Free Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Benadryl 50mg/2mL Pres-Free Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0447-2016·2015-12-09

    Western Drug Recalls PZI 40 Insulin Due to Sterility Concerns

    Western Drug is recalling 9 containers of PZI 40 Insulin (Human) because the product lacks assurance of sterility.

    Product
    PZI 40 Insulin (Human) Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0433-2016·2015-12-09

    Western Drug Recalls Ketorolac Injection Due to Sterility Concerns

    Western Drug Inc. is recalling Ketorolac 40mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Ketorolac 40mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0439-2016·2015-12-09

    Western Drug Recalls Novarel HCG Vials Due to Sterility Concerns

    Western Drug is recalling Novarel HCG 10000U/Vial prescription vials nationwide due to a lack of assurance of sterility.

    Product
    Novarel "HCG" 10000U/Vial, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0498-2016·2015-12-09

    Life Science Pharmacy Recalls BI-EST Lozenges Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling BI-EST Lozenges because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.

    Product
    BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2016·2015-12-09

    Western Drug Recalls Hydrochloric Acid Injection Due to Sterility Concerns

    Western Drug is recalling Hydrochloric Acid 2mg Injection because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Hydrochloric Acid 2mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0466-2016·2015-12-09

    Western Drug Recalls Verapamil Injection Due to Sterility Concerns

    Western Drug is recalling Verapamil 120mg/12mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Verapamil 120mg/12mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0418-2016·2015-12-09

    Western Drug Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Western Drug is recalling Ascorbic Acid 500 mg/mL Injection because the product lacks assurance of sterility. The recall covers six containers distributed nationwide.

    Product
    Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0502-2016·2015-12-09

    Life Science Pharmacy Recalls TRI-EST Lozenges Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling TRI-EST Lozenges due to potential penicillin cross-contamination. The recall covers all lots distributed nationwide.

    Product
    TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0507-2016·2015-12-09

    Life Science Pharmacy Recalls HCG Injections Due to Penicillin Contamination

    Life Science Pharmacy Inc. is recalling Human Chorionic Gonadotropin (HCG) injections nationwide due to potential penicillin cross-contamination.

    Product
    HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0409-2016·2015-12-09

    Western Drug Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Western Drug is recalling Hydroxocobalamin 1mg/mL Injection because the product lacks assurance of sterility. The recall covers three containers distributed nationwide.

    Product
    Hydroxocobalamin 1mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0465-2016·2015-12-09

    Western Drug Recalls Tri-Test Injection Due to Sterility Concerns

    Western Drug is recalling 3 containers of Tri-Test 1:1:1 300mg/mL Injection because the product lacks assurance of sterility.

    Product
    Tri-Test 1:1:1 300mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide

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