The Recall Desk

Archive

January 2018 recalls

494 recalls were announced in January 2018.

What the numbers show

Critical
39
Severe
136
High
162
Moderate
138
Low
19

Of the 494 recalls this month scored against our rubric, 8% are Critical, 28% are Severe.

Which agencies issued them

201–300 of 494

  • ModerateFDA (Drugs)·D-0215-2018·2018-01-24

    Shiseido Sunscreen Recalled for Manufacturing Quality Deviations

    Shiseido America Inc. is recalling Future Solution LX Universal Defense SPF 50+ sunscreen because the manufacturing of active ingredient material did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0600-2018·2018-01-24

    Ventura Foods Recalls Smokehouse 220 Barbecue Sauce Due to Plastic Foreign Object

    Ventura Foods is recalling Smokehouse 220 Sweet & Spicy Barbecue Sauce because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Smokehouse 220 Sweet & Spicy Barbecue Sauce; Net Wt. 16 OZ.; Ventura Foods, Brea, CA 92823; Coded: 05 30 18.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0338-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0216-2018·2018-01-24

    Shiseido Future Solution LX Discovery Set Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Discovery Set because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0593-2018·2018-01-24

    Ventura Foods Recalls Sysco Imperial Glazed Hot Bacon Dressing Due to Plastic Foreign Object

    Ventura Foods is recalling Sysco Imperial Glazed Hot Bacon Dressing because a plastic foreign object was inadvertently introduced into the product stream.

    Product
    Sysco Imperial Glazed Hot Bacon Dressing; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: B12917
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0340-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 16 units of Tryptik 2 C-Plate Self Tapping screws distributed in California because the product labeling contains an incorrect sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0339-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error

    Spineart SA is recalling 9 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling displays a sketch of a self-drilling screw instead of the correct self-tapping screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0342-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 8 units of Tryptik 2 C-Plate Self Tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0336-2018·2018-01-24

    Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error

    Spineart SA is recalling 54 units of Tryptik 2 C-Plate self-tapping screws because the product labeling incorrectly displays a sketch of a self-drilling screw.

    Product
    TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0219-2018·2018-01-24

    Shionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles

    Shionogi Inc. is recalling 968 bottles of Mefenamic Acid Capsules, 250 mg, due to the presence of black particles found during routine stability testing.

    Product
    Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·005-2018·2018-01-23

    Perdue Recalls Chicken Fritters Due to Undeclared Egg Allergen

    Perdue Foods is recalling approximately 530 pounds of chicken breast tenderloin fritters because they contain egg whites, an undeclared allergen.

    Product
    Perdue Foods LLC — Perdue Foods LLC Recalls Chicken Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·18V064000·2018-01-22

    Suzuki Recalls 2017-2018 GSX-R1000 Motorcycles for Chain Break Risk

    Suzuki is recalling 2017-2018 GSX-R1000 motorcycles because a gear shift error can cause the drive chain to break, leading to power loss and crash risk.

    Product
    SUZUKI — SUZUKI GSX-R1000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V060000·2018-01-22

    Wayfarer Recalls 2017 24 QW RVs for Defective Fire Extinguishers

    Wayfarer is recalling 2017 24 QW recreational vehicles because the installed Kidde fire extinguishers may clog or detach, potentially failing to function during a fire.

    Product
    WAYFARER — WAYFARER 24 QW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V066000·2018-01-22

    Forest River Recalls 2018 Cherokee Trailers for Lighting Defects

    Forest River is recalling 2018 Cherokee recreational trailers because side marker lights are improperly positioned and reflectors may be missing, reducing visibility.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V065000·2018-01-19

    Aston Martin Recalls 2017-2018 DB11 Vehicles for Air Bag Defect

    Aston Martin is recalling 2017-2018 DB11 V12 and V8 Coupe vehicles because the driver's frontal air bag may deploy unexpectedly due to insufficient grounding.

    Product
    ASTON MARTIN — ASTON MARTIN DB11
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V062000·2018-01-19

    Newmar Recalls 2017-2018 Motorhomes Due to Headlight Visibility Defect

    Newmar is recalling 2017-2018 Ventana and Dutch Star motorhomes because low beam headlights do not illuminate with high beams, reducing visibility.

    Product
    NEWMAR — NEWMAR VENTANA, DUTCH STAR, VENTANA LE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18081·2018-01-19

    Panasonic Recalls 55-Inch Televisions and Swivel Stands Due to Tip-Over Hazard

    Panasonic is recalling 55-inch flat screen televisions with tabletop swivel stands because the mounting screws can loosen, causing the TV to tip over and potentially injure or kill children.

    Product
    Panasonic 55-inch flat screen LED/LCD televisions with tabletop swivel stands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·004-2018·2018-01-18

    Café Spice Recalls Chicken Salad Products Due to Undeclared Milk Allergen

    Café Spice GCT Inc. is recalling ready-to-eat chicken salad products because they contain milk, an undeclared allergen, and are mislabeled as chicken wraps.

    Product
    CAFE SPICE LLC — Café Spice GCT Inc., Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·18080·2018-01-18

    Bed Bath & Beyond Recalls UGG Hudson Comforters Due to Mold Risk

    Bed Bath & Beyond is recalling UGG Hudson comforters due to a risk of mold exposure. Consumers should stop using the products and return them for a full refund.

    Product
    Hudson comforters by UGG
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18715·2018-01-18

    Hillsdale Furniture Recalls Bar Stools Due to Fall Hazard

    Hillsdale Furniture is recalling Polston and Collin bar stools because the seat can loosen or break off, posing a fall hazard. No injuries have been reported.

    Product
    Bar stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·003-2018·2018-01-18

    Duke Sandwich Productions Recalls Chicken Salad Due to Misbranding

    Duke Sandwich Productions is recalling approximately 743 pounds of chicken salad products because they were packaged in pimento cheese containers with mismatched labels.

    Product
    DiscoverFresh Foods — Duke Sandwich Productions, Inc. Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0566-2018·2018-01-17

    Nodine's Smokehouse Recalls Smoked Salmon Due to Listeria Risk

    Nodine's Smokehouse Inc. is recalling smoked salmon packages nationwide due to potential Listeria monocytogenes contamination.

    Product
    Smoked salmon in 1.5 oz. and 8 oz. packages
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0564-2018·2018-01-17

    Haldiram's Fresh Paneer Recalled Due to Listeria monocytogenes Contamination

    Kotecha Brothers LLC is recalling Haldiram's Fresh Paneer after a sample tested positive for Listeria monocytogenes. The product was distributed to Florida consignees.

    Product
    Haldiram's Fresh Paneer Traditional Indian Soft Cottage Cheese, Net Weight 800g (28.2 oz)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0159-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 130,740 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0638-2018·2018-01-17

    Jack Brown Produce Recalls Fuji Apples for Listeria Contamination Risk

    Jack Brown Produce is voluntarily recalling Fuji apples due to potential Listeria monocytogenes contamination reported by a supplier.

    Product
    Fuji, whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0617-2018·2018-01-17

    Nyblad Orchards Recalls Honeycrisp Apples Due to Listeria Risk

    Nyblad Orchards is voluntarily recalling Honeycrisp apples due to potential Listeria monocytogenes contamination. The recall covers various package sizes distributed in Michigan.

    Product
    Honey crisp, whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic container boxes " 50ct…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0639-2018·2018-01-17

    Jack Brown Produce Recalls Golden Delicious Apples Due to Listeria Risk

    Jack Brown Produce is voluntarily recalling Golden Delicious apples due to potential Listeria monocytogenes contamination. The recall affects specific lots distributed in five US states.

    Product
    Golden Delicious whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0559-2018·2018-01-17

    New Seasons Market Macaroni and Cheese Recalled for Undeclared Egg

    New Seasons Market is recalling pre-packaged macaroni and cheese due to undeclared egg. The product was sold in California, Oregon, and Washington.

    Product
    New Seasons Market Grab and Go Pre-Packaged Macaroni and Cheese - refrigerated. Product is packaged in aluminum shallow containers with a clear plastic dome lid and sold in two sizes: Small package UPC 252089 203999. Large package UPC 252090 706991. The label is read…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0618-2018·2018-01-17

    Nyblad Orchards Recalls Fuji Apples Due to Listeria Risk

    Nyblad Orchards is voluntarily recalling Fuji apples due to potential Listeria monocytogenes contamination. The recall covers various package sizes distributed in Michigan.

    Product
    Fuji, whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic container boxes " 50ct, individual…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0293-2018·2018-01-17

    Edwards Certitude Delivery System Recalled for Molding Overflow Defect

    Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.

    Product
    Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA)…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0208-2018·2018-01-17

    Teva Recalls Moexipril Hydrochloride Tablets Due to Impurity Test Failure

    Teva Pharmaceuticals is recalling specific bottles of Moexipril Hydrochloride and Hydrochlorothiazide tablets because routine stability testing found high levels of a degradation impurity.

    Product
    Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0640-2018·2018-01-17

    Jack Brown Produce Recalls Apples Due to Listeria Risk

    Jack Brown Produce is voluntarily recalling multiple varieties of apples because they may be contaminated with Listeria monocytogenes.

    Product
    Golden Del., Gala, Fuji, Honey Crisp; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0619-2018·2018-01-17

    Nyblad Orchards Recalls Fresh Apples Due to Listeria Risk

    Nyblad Orchards is voluntarily recalling multiple varieties of fresh apples due to potential contamination with Listeria monocytogenes.

    Product
    Gala, Fuji., honey crisp, golden delicious whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0212-2018·2018-01-17

    Pfizer Recalls Atorvastatin Tablets Due to Microbial Contamination

    Pfizer is recalling specific export-only batches of atorvastatin calcium tablets due to microbial contamination. No product was distributed in the United States.

    Product
    FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0157-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 29,232 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0565-2018·2018-01-17

    Daisy's Bakery Recalls Gourmet Concha for Undeclared Milk Allergen

    Daisy's Bakery Inc. is recalling Gourmet Concha products because they contain an undeclared milk allergen. The mislabeled items were distributed to five states.

    Product
    Daisy s Bakery Inc., Gourmet Concha, 4 oz. / 1 per package, Plastic Bag, 12 units per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0637-2018·2018-01-17

    Jack Brown Produce Recalls Gala Apples Due to Listeria Risk

    Jack Brown Produce is voluntarily recalling specific lots of Gala apples due to potential Listeria monocytogenes contamination.

    Product
    Gala, whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5trays per case), 55, 60, 78ct (2trays per RPC case) 2# & 3# - 12 bags per case, 5# - 8 bags per case
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0160-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 96,828 bottles of sterile eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0616-2018·2018-01-17

    Nyblad Orchards Recalls Fresh Apples Due to Listeria Risk

    Nyblad Orchards is voluntarily recalling multiple varieties of Golden Delicious apples due to potential Listeria monocytogenes contamination.

    Product
    Golden delicious whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic container boxes " 50ct…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0330-2018·2018-01-17

    Philips CombiDiagnost R90 X-Ray System Recalled for Electrical Safety Defect

    Philips is recalling 10 CombiDiagnost R90 X-ray systems because a protective earthing wire was removed and non-standard spacers were used.

    Product
    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0158-2018·2018-01-17

    Smiths Medical Recalls Sterile Eyewash Due to Leaking Containers

    Smiths Medical is recalling 22,080 bottles of Sterile Eyewash because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0294-2018·2018-01-17

    Physio-Control Recalls LIFEPAK 20e Defibrillators Due to Power Failures

    Physio-Control is recalling 3,831 LIFEPAK 20e defibrillators because power-related failures could prevent the device from delivering therapy, potentially causing serious injury or death.

    Product
    LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0328-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Tibial Punch because the guide did not sufficiently direct the punch, causing implants to be placed further back than intended.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0322-2018·2018-01-17

    CareFusion Recalls Alaris Syringe Pumps Due to Plunger Gripper Failure

    CareFusion is recalling Alaris Syringe Pump Model 8110 units because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2018·2018-01-17

    Cordis S.M.A.R.T. Flex Biliary Stent System Recalled for Cracked Luer Hubs

    Cordis Corporation is recalling 511 units of the S.M.A.R.T. Flex Biliary Stent System due to a potential for cracked luer hubs.

    Product
    Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0562-2018·2018-01-17

    Harrisburg Dairies Recalls Egg Nog for Undeclared Egg Yolk Ingredient

    Harrisburg Dairies is recalling 365 brand and Harrisburg Dairies brand Egg Nog because dried egg yolks were not listed in the ingredient statement.

    Product
    365 brand Egg Nog, Grade A; 1 qt. and 1/2 GAL; and Harrisburg Dairies brand Egg Nog, Grade A; 1/2 GAL, 1 Quart, 16 FL. OZ.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-0655-2018·2018-01-17

    Lovebiotics Recalls Coconut Yogurt for Undeclared Milk Allergen

    Lovebiotics, LLC is recalling The Coconut Cult Mango Cream Probiotic Coconut Yogurt because the allergen statement lists sodium caseinate but fails to identify milk as the source.

    Product
    The Coconut Cult Mango Cream Probiotic Coconut Yogurt NET WT. 8 OZ, 16 OZ, 32 OZ UPC 611138765244, 611138765251, 611138765237
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0332-2018·2018-01-17

    Philips Brilliance iCT SP CT Scanner Recall Due to Loose Screws

    Philips is recalling 134 Brilliance iCT SP CT scanners because screws holding the internal gantry may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT SP computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0329-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Porous Knee System Tibial Punch because the locking guide failed to properly guide the punch, causing implants to be placed 2-3mm more posterior than intended.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0258-2018·2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0001. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2018·2018-01-17

    Orthoscan Mobile Mini C-arm System Recalled for Software Defect

    Orthoscan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than is visible to the user.

    Product
    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0560-2018·2018-01-17

    Ingles Markets Recalls Frozen Biscuits for Listeria Contamination

    Ingles Markets is recalling frozen Southern Style Biscuits after testing revealed Listeria monocytogenes contamination. The product was distributed in Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    Frozen Southern Style Biscuits; 25 oz. bags (12 count)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0561-2018·2018-01-17

    Ingles Markets Recalls Frozen Buttermilk Biscuits Due to Listeria

    Ingles Markets is recalling specific bags of frozen buttermilk biscuits because testing found Listeria monocytogenes. Consumers in Georgia, North Carolina, South Carolina, and Tennessee should not eat the product.

    Product
    Frozen Buttermilk Biscuits 25 oz. bag (12 count) and 44 oz. bag (20 count)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0321-2018·2018-01-17

    Ambu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures

    King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.

    Product
    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z…
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0326-2018·2018-01-17

    Encore Medical Recalls DJO EMPOWR Knee Locking Tibial Punch Guide

    Encore Medical is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide because the device did not sufficiently guide the punch, causing implants to be placed 2-3mm more posterior than intended.

    Product
    DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0261-2018·2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2018·2018-01-17

    Philips Brilliance iCT CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling 702 Brilliance iCT computed tomography systems because screws holding an internal gantry component may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0318-2018·2018-01-17

    Repro-Med HIgH-Flo Subcutaneous Safety Needle Sets Recalled for Packaging Defects

    Repro-Med Systems is recalling HIgH-Flo Subcutaneous Safety Needle Sets because gaps were found in the sterile barrier packaging during post-sterilization inspection.

    Product
    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2018·2018-01-17

    Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch

    Encore Medical is recalling two units of the EMPOWR Tibial Punch because the locking guide failed to properly position the implant.

    Product
    EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0323-2018·2018-01-17

    CareFusion Alaris PCA Pump Recall Due to Syringe Plunger Gripper Failure

    CareFusion is recalling Alaris PCA Pumps because the syringe plunger grippers may fail to close automatically, potentially affecting medication delivery.

    Product
    Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2018·2018-01-17

    Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

    Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

    Product
    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2018·2018-01-17

    Philips IQon Spectral CT Scanner Recall Due to Potential Gantry Screw Failure

    Philips is recalling IQon Spectral CT systems because screws holding the internal gantry to the main bearing may come loose, potentially causing noise.

    Product
    Philips Healthcare IQon Spectral CT computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0654-2018·2018-01-17

    Lovebiotics Coconut Yogurt Recalled for Undeclared Milk Allergen

    Lovebiotics, LLC is recalling The Coconut Cult Coconut Cream Probiotic Coconut Yogurt because the label lists sodium caseinate but fails to explicitly identify milk as an allergen.

    Product
    The Coconut Cult Coconut Cream Probiotic Coconut Yogurt NET WT. 8 OZ, 16 OZ, 32 OZ UPC 611138765282, 611138765275, 611138765268
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0260-2018·2018-01-17

    OrthoScan Recalls Mobile Mini C-arm Systems Due to Software Defect

    OrthoScan is recalling 2,012 Mobile Mini C-arm systems because a software defect allows users to activate Digital Zoom during live imaging, exposing a larger x-ray field than visible.

    Product
    Mobile Mini C-arm system Part # 1000-0005. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0190-2018·2018-01-17

    KRS Global Biotechnology Recalls QUADMIX #17 Due to Expired Ingredients

    KRS Global Biotechnology is recalling 122 vials of QUADMIX #17 because the product's beyond-use date exceeds the expiration date of at least one ingredient.

    Product
    QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0182-2018·2018-01-17

    KRS Global Biotechnology Recalls Iodochlorhydroxyquin Otic Powder Due to Labeling Error

    KRS Global Biotechnology is recalling 40 jars of Iodochlorhydroxyquin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0171-2018·2018-01-17

    KRS Global Biotechnology Recalls Chloramphenicol Otic Powder Due to Labeling Errors

    KRS Global Biotechnology is recalling 100 jars of Chloramphenicol Otic Powder because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 1,203 vials of Human Chorionic Gonadotropin due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0166-2018·2018-01-17

    KRS Global Biotechnology Recalls Topical Cream Due to Expired Ingredients

    KRS Global Biotechnology is recalling 1,380 jars of Benzocaine, Lidocaine, and Tetracaine Topical Cream because the product's beyond-use date exceeds the expiration dates of its ingredients.

    Product
    Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0178-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Vials for Labeling Errors

    KRS Global Biotechnology is recalling 2,274 vials of Human Chorionic Gonadotropin 20,000 iu due to incorrect or missing lot and expiration dates.

    Product
    Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0200-2018·2018-01-17

    KRS Global Biotechnology Recalls T-105 Vials Due to Expired Ingredient Dates

    KRS Global Biotechnology is recalling 173 vials of T-105 because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0202-2018·2018-01-17

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Labeling Errors

    KRS Global Biotechnology is recalling 81 droptainers of a multi-dose ophthalmic solution because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5% Ophthalmic Soln, 5 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2018·2018-01-17

    Brainlab DrapeLink Adapter Recall Due to Manufacturing Error

    Brainlab AG is recalling DrapeLink Adapters because a supplier error caused some units to not meet specifications.

    Product
    Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0187-2018·2018-01-17

    KRS Global Biotechnology Recalls Prednisolone Tablets Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,000 Prednisolone 10 mg tablets because the expiration date exceeds the stability of an ingredient.

    Product
    PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2018·2018-01-17

    KRS Global Biotechnology Recalls Anastrozole SR Capsules Due to Labeling Errors

    KRS Global Biotechnology is recalling Anastrozole SR 1 mg capsules because the Beyond Use Dates exceed the expiration dates of some ingredients.

    Product
    Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0167-2018·2018-01-17

    KRS Global Biotechnology Recalls Benzo/Lido/Tetracaine Topical Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,280 jars of Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0649-2018·2018-01-17

    Spice Chain Recalls Paprika Powder Due to Beetle Complaints

    Spice Chain Corporation is recalling Paprika Powder HyTop 12/2.5oz after receiving consumer complaints about finding beetles in retail containers.

    Product
    Paprika Powder HyTop 12/2.5oz, Merchants
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0175-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 6,414 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0165-2018·2018-01-17

    KRS Global Biotechnology Recalls Benzocaine Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 4,530 jars of Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0185-2018·2018-01-17

    FDA Recalls Nicotinamide Adenine Dinucleotide Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,535 vials of Nicotinamide Adenine Dinucleotide 500 mg because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0645-2018·2018-01-17

    Spice Chain Recalls Paprika Due to Beetle Complaints

    Spice Chain Corporation is recalling Paprika Sweet American Garden after consumer complaints of finding beetles in retail containers.

    Product
    Paprika Sweet American Garden 12/3.25oz, Global Food Export
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0173-2018·2018-01-17

    KRS Global Recalls Human Chorionic Gonadotropin Tablets Due to Labeling Error

    KRS Global Biotechnology is recalling 2,239 Human Chorionic Gonadotropin tablets because the expiration date exceeds the shelf life of an ingredient.

    Product
    Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0534-2018·2018-01-17

    Publix Southern Style Diced Hash Brown Potatoes Recalled for Foreign Material

    McCain Foods USA is recalling Publix brand Southern Style Diced Hash Brown Potatoes after consumer complaints of foreign material in the product.

    Product
    Publix brand, item # 41596, Southern Style Diced Hash Brown Potatoes, Net wt. 32 oz. Retail's UPC # 0 41415 00549 5. The label is read in parts: "***Publix Southern Style DICED HASH BROWN POTATOES***DISTRIBUTED BY PUBLIX SUPERMARKETS, INC. LAKELAND, FL 33802***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0525-2018·2018-01-17

    Saputo Recalls Light String Cheese Due to Off Odor and Taste

    Saputo Cheese USA Inc. is recalling Light String Cheese sold under multiple brands due to an off odor and off taste.

    Product
    Light String Cheese, Part Skim Mozzarella cheese, sold under the following brands and package sizes: 1. Fit & Active, 10 oz,., 12 individually wrapped pieces. UPC 041498-190293; 2. LIDL, 10 oz., 12 individually wrapped pieces. BEST BY 29MAR18L3 3. Market Pantry…
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0188-2018·2018-01-17

    KRS Global Biotechnology Recalls Progesterone 3% Topical Cream Due to Labeling Errors

    KRS Global Biotechnology is recalling 300 jars of Progesterone 3% Topical Cream because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0192-2018·2018-01-17

    FDA Recalls Savinase Topical Solution Due to Expired Ingredient Labeling

    KRS Global Biotechnology is recalling Savinase 100 mcg/mL Topical Solution because the product's beyond-use date exceeds the expiration date of at least one ingredient.

    Product
    Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2018·2018-01-17

    KRS Global Biotechnology Recalls Amphotericin Otic Powder Due to Labeling Error

    KRS Global Biotechnology is recalling 80 vials of Amphotericin Otic Powder because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0194-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Cartridges Due to Labeling Errors

    KRS Global Biotechnology is recalling 80 Sermorelin cartridges because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0176-2018·2018-01-17

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Labeling Errors

    KRS Global Biotechnology is recalling 2,239 vials of Human Chorionic Gonadotropin because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0195-2018·2018-01-17

    KRS Global Biotechnology Recalls Sermorelin Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 597 vials of Sermorelin and related peptides because the Beyond Use Date exceeds the expiration of at least one ingredient.

    Product
    Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0156-2018·2018-01-17

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Missing Labeling

    SCA Pharmaceuticals is recalling 1,248 syringes of Ephedrine sulfate 5 mg/mL because the product labels were missing the lot number and beyond-use date.

    Product
    Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0204-2018·2018-01-17

    KRS Global Biotechnology Recalls Vitamin 9 A/B Lyophilized Vials Due to Labeling Errors

    KRS Global Biotechnology is recalling 3,612 vials of Vitamin 9 A/B Lyophilized Vials because the Beyond Use Date exceeds the expiration date of at least one ingredient.

    Product
    Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide

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