The Recall Desk

Archive

August 2020 recalls

436 recalls were announced in August 2020.

What the numbers show

Critical
25
Severe
118
High
163
Moderate
122
Low
8

Of the 436 recalls this month scored against our rubric, 6% are Critical, 27% are Severe.

Which agencies issued them

101–200 of 436

  • ModerateFDA (Drugs)·D-1528-2020·2020-08-26

    Calvin Scott Recalls Phentermine HCL Capsules Due to Packaging Defect

    Calvin Scott & Company is recalling Phentermine HCL 30mg capsules because they were repackaged in transparent pouches, exposing the light-sensitive medication to potential degradation.

    Product
    Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1531-2020·2020-08-26

    Calvin Scott Recalls Phentermine Tablets Due to Packaging Deviations

    Calvin Scott & Company is recalling specific lots of Phentermine HCL tablets because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

    Product
    Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1515-2020·2020-08-26

    Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

    Calvin Scott & Co. is recalling Hydrochlorothiazide 25mg tablets because light-sensitive products were repackaged in transparent pouches.

    Product
    Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2020·2020-08-26

    United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue

    Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2812-2020·2020-08-26

    Philips Module Charger Recall for MRI Patient Monitoring System

    Philips is recalling Module Chargers used in the Expression MR400 MRI Patient Monitoring System because poor electrical contact prevents the lithium-polymer battery from charging.

    Product
    Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1516-2020·2020-08-26

    Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

    Calvin Scott & Company is recalling Hydrochlorothiazide 50mg tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2822-2020·2020-08-26

    CareFusion Alaris Pump Module 8100 Recalled for Dim LED Display Segments

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because LED display segments may appear dim, potentially affecting the visibility of infusion or patient monitoring values.

    Product
    Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2810-2020·2020-08-26

    Philips MRI Patient Monitoring System Battery Recall for Charging Failure

    Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

    Product
    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2811-2020·2020-08-26

    Philips Charging Station Recalled Due to Battery Charging Failure

    Philips is recalling charging stations for the Expression MR400 MRI system because the battery fails to charge due to poor electrical contact.

    Product
    Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-1166-2020·2020-08-26

    La Canasta Recalls My Nana's Tortilla Chips for Staleness

    La Canasta Mexican Food Products is recalling My Nana's Thick & Crunchy Tortilla Chips because they turn stale before the expiration date.

    Product
    My Nana's Thick & Crunchy Tortilla Chips, 12 oz. (340g) paper bag (12 bags per case), UPC 0-34392-10161-8.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-1513-2020·2020-08-26

    Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

    Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

    Product
    Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1512-2020·2020-08-26

    Ultra Seal Recalls Pain Relief Tablets Due to Stability Failures

    Ultra Seal Corporation is recalling specific lots of Pain Relief Maximum Strength tablets because they failed stability specifications for salicylic acid.

    Product
    Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·20V500000·2020-08-24

    ETI Recalls 2020 Aerial Lift Trucks Due to Boom Tube Weld Defects

    Equipment Technology is recalling 2020 ETI ETC 37 IH aerial lift trucks because improper welds and steel thickness may cause the platform to fall unexpectedly.

    Product
    ETI — ETI ETC 37 IH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V499000·2020-08-24

    Oshkosh Recalls 2020 S-Series Vehicles for Brake Switch Defect

    Oshkosh is recalling 172 2020 S-Series vehicles because a pressure switch defect may cause air leaks, increased braking distance, or brake light failure.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS· 021-2020 ·2020-08-22

    Oberto Recalls Smoked Sausage for Undeclared Soy Allergen

    Oberto Snacks is recalling 309 pounds of smoked sausage due to misbranding and an undeclared soy allergen. No adverse reactions have been reported.

    Product
    Oberto Snacks Inc. — Oberto Snacks, Inc. Recalls Smoked Sausage Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V496000·2020-08-21

    Autocar Recalls 2019 Xpeditor Vehicles for Potential Stalling Hazard

    Autocar is recalling 78 model year 2019 Xpeditor vehicles up-fitted with an aftermarket power take off (PTO) because they may stall or hesitate, increasing the risk of a crash.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E059000·2020-08-21

    Spyder G9 Electronic Control Units Recalled for Fire Risk

    Spyder Controls is recalling G9 electronic control units that can fail under excessive voltage, causing board damage and an increased risk of fire.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E058000·2020-08-21

    Firefly Integrations Recalls Multiplex G9 Units for Fire Risk

    Firefly Integrations is recalling Multiplex G9 units used in motorhomes because excessive voltage can damage the circuit board, increasing the risk of a fire.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V498000·2020-08-21

    Thor Motor Coach motorhomes recalled for potential electrical fire risk

    Thor Motor Coach is recalling 2019-2021 Windsport and Hurricane motorhomes due to a circuit board defect that could cause fire. The electrical control center may be damaged by voltages over 17 volts.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH HURRICANE, WINDSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E057000·2020-08-20

    Motorcar Parts Recalls Duralast Brake Master Cylinders for Volkswagen Models

    Motorcar Parts of America is recalling specific Duralast brake master cylinders for Volkswagen vehicles due to a defect that may cause loss of braking.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:MASTER CYLINDER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V495000·2020-08-20

    2021 BMW Motorcycles Recalled for Detachable Tire Pressure Labels

    BMW is recalling 2021 R 1250 motorcycles (R, RT, RS, GS models) because tire pressure labels may detach from the frame. Without proper tire pressure information readily available, riders risk improper tire inflation, affecting handling and control.

    Product
    BMW — BMW R 1250 RS, R 1250 RT, R 1250 R, R 1250 GS ADVENTURE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1145-2020·2020-08-19

    Whole Foods Recalls Kouign-Amann Pastries for Potential Undeclared Eggs

    Whole Foods Market is recalling Kouign-Amann pastries due to a potential undeclared egg allergen. The recall affects 102 units sold in seven states.

    Product
    Kouign-Amann Pastry available in plastic clamshell 4-packs with Whole Foods Market scale labels, a PLU code 26739400000
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Drugs)·D-1538-2020·2020-08-19

    Itech 361 LLC Recalls All Clean Hand Sanitizer Due to Methanol

    Itech 361 LLC is recalling 18,760 bottles of All Clean Hand Sanitizer because the product contains undeclared methanol.

    Product
    All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1150-2020·2020-08-19

    Iron (III) Hydroxide Polysaccharides Complex Recalled for Undeclared Milk Allergen

    Advanced Compounds International is recalling Iron (III) Hydroxide Polysaccharides Complex because the product contains an undeclared milk allergen.

    Product
    Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1147-2020·2020-08-19

    Wellements Iron Drops Recalled for Undeclared Milk Allergen

    Wellements LLC is recalling Iron Drops liquid dietary supplements because they contain undeclared milk. Consumers with milk allergies should not use the product.

    Product
    Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1146-2020·2020-08-19

    Island Spring Organics Tofu Recalled Due to Metal Fragment

    Island Spring Inc is recalling 120 cases of Extra Firm Organic Tofu because a customer found a metal fragment in the product.

    Product
    Island Spring Organics Extra Firm Organic Tofu, brand iXF-W12. Product is packaged in small square shapes into vacuum sealed pouches, net wt. 12 oz. Product is refrigerated. UPC is 0 74899 00006 9. The product label is read in parts: "***ISLAND SPRING ORGANICS Extra Firm…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2794-2020·2020-08-19

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

    Product
    Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1149-2020·2020-08-19

    Upspring Baby Iron Supplement Recalled for Undeclared Milk

    Upspring, Ltd. is recalling 10,328 units of UpSpring Baby Iron + Immunity dietary supplements because they may contain undeclared milk.

    Product
    UpSpring Baby Iron + Immunity MULTI + IRON + ZINC Promotes nutrition For Healthy Growth + Immune System Support For Infants 4 months + Natural Grape Flavor Easy To Use Dropper Dietary Supplement NET WT 2 FL OZ (60 ML)UPC No: 859188006805 packaged in dark brown glass bottles and…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2795-2020·2020-08-19

    Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk

    Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.

    Product
    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1148-2020·2020-08-19

    Wellements Iron Drops Sampler Recalled for Undeclared Milk

    Wellements LLC is recalling Iron Drops Sampler liquid dietary supplements because the product contains undeclared milk.

    Product
    Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL, (2 mL fill) amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E056000·2020-08-19

    Tong Yang Recalls Grille Mouldings for 2019-2020 Honda HR-V Vehicles

    Tong Yang is recalling aftermarket grille mouldings for 2019-2020 Honda HR-Vs because the coating may interfere with the Adaptive Cruise Control radar sensor, increasing crash risk.

    Product
    STRUCTURE:BODY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1322-2020·2020-08-19

    San Francisco Street Bakery Onion Bagels Recalled for Undeclared Soy

    San Francisco Street Bakery is recalling Onion Bagels because they contain soy lecithin, an ingredient not listed on the product label.

    Product
    Onion Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: ONION BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin C, Niacin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2780-2020·2020-08-19

    Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit

    Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.

    Product
    Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.

    Product
    Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1332-2020·2020-08-19

    San Francisco Street Bakery Recalls Pain Au Levain Bread for Undeclared Soy

    San Francisco Street Bakery Inc. is recalling 62 loaves of Pain Au Levain Bread because the product contains soy lecithin, which is not declared on the label.

    Product
    Pain Au Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 16 oz (454 g). UPC 0 08613 10013 1. The product label is read in parts: "***Pain Au Levain Bread ***Ingredients: unbleached wheat flour…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1321-2020·2020-08-19

    San Francisco Street Bakery Garlic Bagels Recalled for Undeclared Soy

    San Francisco Street Bakery is recalling Garlic Bagels produced in July 2020 because they contain soy lecithin, an ingredient not listed on the label.

    Product
    Garlic Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: GARLIC BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin C…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1330-2020·2020-08-19

    San Francisco Street Bakery Recalls Italian Farm Bread for Undeclared Soy

    San Francisco Street Bakery is recalling 34 loaves of Italian Farm Bread because the product contains soy lecithin, which is not declared on the label.

    Product
    Italian Farm Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 23 oz (652 g). UPC 0 08613 10005 6. The product label is read in parts: "***Italian Farm Bread ***Ingredients: unbleached wheat flour…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1495-2020·2020-08-19

    SCA Pharmaceuticals Recalls Heparin Sodium Bags Due to Low Potency

    SCA Pharmaceuticals is recalling 3,932 bags of Heparin Sodium 5,000 units due to out-of-specification potency results at the 30-day stability timepoint.

    Product
    Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V491000·2020-08-19

    2021 Keystone Outback travel trailers recalled for incorrect tire pressure label

    Keystone is recalling certain 2021 Outback travel trailers because the Federal Identification Tag incorrectly states tire pressure should be 65 PSI instead of the correct 80 PSI. Underinflated tires could fail and increase crash risk.

    Product
    KEYSTONE — KEYSTONE OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1333-2020·2020-08-19

    San Francisco Street Bakery Recalls Rosemary Garlic French Bread for Undeclared Soy

    San Francisco Street Bakery is recalling 36 units of Rosemary Garlic French Bread because the product contains soy lecithin, which is not declared on the label.

    Product
    Rosemary Garlic French Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 14 oz (400 g). UPC 0 08613 10008 7. The product label is read in parts: "***Rosemary Garlic French Bread***Ingredients…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1328-2020·2020-08-19

    San Francisco Street Bakery Recalls Desem Bread for Undeclared Soy

    San Francisco Street Bakery is recalling 14 loaves of Desem Bread because the product contains soy lecithin, which is not declared on the label.

    Product
    Desem Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 22 oz. UPC 0 08613 10001 8. The product label read: "***desem ***Ingredients: stone ground organic whole wheat flour, water, organic wheat flour…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2773-2020·2020-08-19

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1327-2020·2020-08-19

    San Francisco Street Bakery Recalls Sesame Seed Bagels Due to Undeclared Soy

    San Francisco Street Bakery is recalling Sesame Seed Bagels because the product contains soy lecithin, which is not declared on the label.

    Product
    Sesame Seed Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: SESAME SEED BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1320-2020·2020-08-19

    San Francisco Street Bakery Recalls Everything Bagels Due to Undeclared Soy

    San Francisco Street Bakery is recalling Everything Bagels produced in July 2020 because the product contains soy lecithin, which is not listed on the label.

    Product
    Everything Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: EVERYTHING BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1323-2020·2020-08-19

    San Francisco Street Bakery Recalls Pesto Bagels for Undeclared Soy

    San Francisco Street Bakery is recalling 55 Pesto Bagels because they were treated with a pan release spray containing soy lecithin, which is not listed on the label.

    Product
    Pesto Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: PESTO BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin C, Niacin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1501-2020·2020-08-19

    Eosera Recalls Ear Itch MD Sprays Due to Manufacturing Deviations

    Eosera, Inc. is voluntarily recalling specific lots of Ear Itch MD sprays nationwide due to cGMP deviations.

    Product
    Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1324-2020·2020-08-19

    San Francisco Street Bakery Plain Bagels Recalled for Undeclared Soy

    San Francisco Street Bakery is recalling Plain Bagels because pan release spray containing soy lecithin was used on equipment and finished products, but the label does not declare soy.

    Product
    Plain Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: PLAIN BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin C, Niacin…
    Category
    Food
    Distribution
    1 state
  • HighCPSC·20168·2020-08-19

    Hasbro Recalls Super Soaker XP 20 and XP 30 Water Blasters for Lead Content

    Hasbro is recalling Super Soaker XP 20 and XP 30 water blasters because decorative stickers contain lead levels exceeding federal bans. No injuries have been reported.

    Product
    Super Soaker XP 20 and Super Soaker XP 30
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2020·2020-08-19

    Anjon Holdings Recalls Spinal Bone Fixation Fasteners Due to Galling

    Anjon Holdings is recalling 249 Anjon Bremer Molded Crown bone fixation fasteners because of a high rate of galling in a threaded component.

    Product
    Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1326-2020·2020-08-19

    San Francisco Street Bakery Salt Bagels Recalled for Undeclared Soy

    San Francisco Street Bakery is recalling Salt Bagels because they were treated with a pan release spray containing soy lecithin, which is not listed on the product label.

    Product
    Salt Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: SALT BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin C, Niacin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1325-2020·2020-08-19

    San Francisco Street Bakery Recalls Poppy Seed Bagels Due to Soy Allergen

    San Francisco Street Bakery is recalling Poppy Seed Bagels because they were treated with a pan release spray containing soy lecithin, which is not declared on the label.

    Product
    Poppy Seed Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: POPPY SEED BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1319-2020·2020-08-19

    San Francisco Street Bakery Recalls Cinnamon Raisin Bagels for Undeclared Soy

    San Francisco Street Bakery is recalling Cinnamon Raisin Bagels because they contain soy lecithin, which is not declared on the label.

    Product
    Cinnamon Raisin Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: CINNAMON RAISIN BAGELS: Bread Flour (Unbleached Wheat…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1500-2020·2020-08-19

    Eosera Recalls Ear Itch MD Anti-Itch Spray Due to cGMP Deviations

    Eosera, Inc. is voluntarily recalling 43,424 bottles of Ear Itch MD Anti-Itch Spray due to cGMP deviations. The product was distributed nationwide in the United States.

    Product
    Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1318-2020·2020-08-19

    San Francisco Street Bakery Recalls Cheddar Bagels Due to Undeclared Soy

    San Francisco Street Bakery Inc. is recalling 52 Cheddar Bagels produced in July 2020 because the product contains soy lecithin, which is not declared on the label.

    Product
    Cheddar Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product label read: CHEDDAR CHEESE BAGEL: Bread Flour (Unbleached Wheat Flour, Vitamin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1334-2020·2020-08-19

    San Francisco Street Bakery Sourdough Rye Bread Recalled for Undeclared Soy

    San Francisco Street Bakery Inc. is recalling Sourdough Rye Bread because the product was treated with pan release spray containing soy lecithin, which is not declared on the label.

    Product
    Sourdough Rye Bread, San Francisco Street Bakery brand, keep at ambient temperature. Sold as an individual unit through on-site retail store bulk display, net weight unknown. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2770-2020·2020-08-19

    Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2799-2020·2020-08-19

    United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges

    Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.

    Product
    uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2020·2020-08-19

    United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects

    Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.

    Product
    uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V492000·2020-08-19

    Spartan Fire Gladiator Recalled for Excessively Bright Exterior Lights

    Spartan Fire is recalling one 2018 Gladiator vehicle because its exterior LED lights may be too bright, potentially blinding other drivers and increasing crash risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2020·2020-08-19

    Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1329-2020·2020-08-19

    San Francisco Street Bakery Recalls French Bread for Undeclared Soy

    San Francisco Street Bakery Inc. is recalling 10 loaves of French Bread sold in Washington because the product contains soy lecithin, which is not declared on the label.

    Product
    French Bread, San Francisco Street Bakery brand, keep at ambient temperature. French Bread sold as an individual unit through the firm's on-site retail store, net weight unknown. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2776-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.

    Product
    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1155-2020·2020-08-19

    Marketside Peanut Butter Brownies Recalled for Missing Allergen Labeling

    James Skinner Baking Co. is recalling Marketside Peanut Butter Brownies because units may lack the ingredient list, failing to declare major allergens including peanuts, wheat, milk, egg, and soy.

    Product
    Marketside Peanut Butter Brownie, Net Wt. 19 oz, Distributed by Walmart Inc. Bentonville, AR
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2793-2020·2020-08-19

    Brainlab Kick Navigation Station Recalled for Incorrect Calibration

    Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.

    Product
    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1331-2020·2020-08-19

    San Francisco Street Bakery Recalls Olive Levain Bread for Undeclared Soy

    San Francisco Street Bakery is recalling Olive Levain Bread because it contains soy lecithin, an ingredient not listed on the label.

    Product
    Olive Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 16 oz (454 g). UPC 0 088613 10014 8. The product label is read in parts: "***Olive Levain Bread ***Ingredients: unbleached bread flour…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1153-2020·2020-08-19

    Sweeteeth Chocolate Bar Recalled for Unlabeled Soy Allergen

    Sweeteeth Chocolate LLC is recalling White Chocolate & Ginger Snaps bars because they contain soy, which is not listed on the label.

    Product
    Sweeteeth O-Snap! (White Chocolate & Ginger Snaps) Chocolate Bar, NET WT. 3 OZ. (85.05G), Manufactured by: Sweeteeth Chocolate LLC. 1204 McNew St. Hanahan, SC 29410 www.evopizza.com, Best By: 07/28/2021, UPC 7 36211 11895 0
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1152-2020·2020-08-19

    Indianapolis Fruit Company Recalls Garden Cut Organic Coleslaw Due to Plastic

    Indianapolis Fruit Company is recalling Garden Cut Organic Coleslaw w/ Carrots because pieces of plastic were found in the finished product.

    Product
    Garden Cut Organic Coleslaw w/ Carrots, retail unit packaged in 1lb clam-shell, 4 retail units per wholesale case, retail unit UPC: 053495081016
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2804-2020·2020-08-19

    Arrow International Recalls NextStep Retrograde Replacement Hub Set Due to Labeling Error

    Arrow International is recalling NextStep Retrograde Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2789-2020·2020-08-19

    HF Acquisition Recalls Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling 95 STAT KIT Model SM30 emergency medical kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2782-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because they were manufactured with a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1498-2020·2020-08-19

    Eosera Recalls Ear Pain MD Pain Relief Drops For Kids

    Eosera, Inc. is voluntarily recalling 45,673 bottles of Ear Pain MD Pain Relief Drops For Kids due to cGMP deviations.

    Product
    Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2784-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1494-2020·2020-08-19

    FDA Recalls Nystatin Oral Suspension Due to Subpotent Drug Levels

    Pharmaceutical Associates, Inc. is recalling Nystatin Oral Suspension because it failed potency testing. Patients should consult their healthcare provider.

    Product
    NYSTATIN — NYSTATIN (NYSTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2803-2020·2020-08-19

    Arrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling TheraCath Epidural Catheters because the lidstock displays an incorrect expiration date, potentially leading to the use of expired devices.

    Product
    Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1154-2020·2020-08-19

    Hostess Raspberry Zingers Recalled for Potential Mold Growth

    Hostess Brands is recalling 34,409 cases of Raspberry Zingers cakes nationwide due to potential mold growth prior to the best-by date.

    Product
    Hostess Raspberry Zingers, Raspberry Iced Cake With Creamy Fillling, packaged in the following ways: 1) in boxes containing 10 cakes Net Wt. 13.4 OZ (380 g) UPC 88109110604 and 2) in clear plastic bags containing 3 cakes Net Wt. 4.02 OZ (114 g) UPC 888109010089
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2786-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material

    Flower Orthopedics is recalling 25 calcaneus plates because the manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2802-2020·2020-08-19

    Arrow International Recalls Cannon II Plus Replacement Hub Sets for Labeling Error

    Arrow International Inc is recalling Cannon II Plus Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2788-2020·2020-08-19

    HealthFirst Emergency Medical Kit Recalled for Missing Narcan Dose

    HF Acquisition Co. is recalling HealthFirst Emergency Medical Kits because they contain one dose of Narcan nasal spray instead of two.

    Product
    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number…
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2791-2020·2020-08-19

    HF Acquisition Recalls STAT KIT Emergency Medical Kits with Missing Narcan Dose

    HF Acquisition Co., LLC is recalling STAT KIT Model 550AI Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2779-2020·2020-08-19

    HealthFirst STAT KIT Z-1000 Emergency Medical Kits Recalled for Missing Component

    HF Acquisition Co. LLC is recalling two STAT KIT Z-1000 emergency medical kits because they are missing a hand suction pump component.

    Product
    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1157-2020·2020-08-19

    Uncommon Canning Recalls Strongbrew CBD Cold Brew Coffee for Storage Issues

    Uncommon Canning LLC is recalling 5,754 cans of Strongbrew CBD Infused Cold Brew Coffee because the product was not stored under refrigeration prior to shipment.

    Product
    Strongbrew CBD Infused Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 71203869615
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2792-2020·2020-08-19

    Brainlab Curve Navigation Stations Recalled for Incorrect Manufacturer Calibration

    Brainlab AG is recalling 18 Curve navigation stations due to incorrect manufacturer calibration. The devices were distributed in the US and internationally.

    Product
    BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-1156-2020·2020-08-19

    Strongbrew Cold Brew Coffee Recalled for Lack of Refrigeration

    Uncommon Canning LLC is recalling Strongbrew Cold Brew Coffee because it was not stored under refrigeration prior to shipment.

    Product
    Strongbrew Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 898577002141
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1492-2020·2020-08-19

    Teva Recalls Lidocaine Patches Due to Missing Lot and Expiration Dates

    Teva Pharmaceuticals is recalling Lidocaine 5% Patches because individual pouches are missing lot and expiration dates. The recall covers 28,596 cartons distributed nationwide.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2790-2020·2020-08-19

    HF Acquisition Recalls STAT KIT 550 Emergency Medical Kits

    HF Acquisition Co., LLC is recalling 155 STAT KIT Model 550 Emergency Medical Kits because they contain one dose of Narcan Nasal spray instead of two.

    Product
    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2787-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 Calcaneus Plates, Extensile, Large, Right (Catalog Number CPF 203) because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1496-2020·2020-08-19

    Taro Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure

    Taro Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream 0.05% because the bulk material failed content uniformity testing.

    Product
    Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide

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