The Recall Desk

Archive

April 2023 recalls

411 recalls were announced in April 2023.

What the numbers show

Critical
6
Severe
53
High
277
Moderate
71
Low
4

Of the 411 recalls this month scored against our rubric, 1% are Critical, 13% are Severe.

301–400 of 411

  • HighNHTSA·23V258000·2023-04-07

    2023 Subaru Ascent Tire Bead Damage Increases Crash Risk

    Subaru is recalling certain 2023 Ascent vehicles equipped with 20-inch wheels due to potential tire bead damage during manufacturing. The defect may cause sudden air pressure loss and increase crash risk.

    Product
    SUBARU — SUBARU ASCENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V256000·2023-04-07

    Alamo Group Recalls 2014-2019 Super Products Camel and Mud Dog Trailers

    Alamo Group is recalling 2014-2019 Super Products Camel and Mud Dog trailers because a tie rod could disconnect, allowing the water tank strap to detach and become a road hazard.

    Product
    SUPER PRODUCTS — SUPER PRODUCTS CAMEL, MUD DOG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V254000·2023-04-07

    Starcraft Prodigy School Buses Recalled for Ceiling Panel Defect

    Forest River Bus is recalling 2019-2022 Starcraft Prodigy school buses because improperly secured ceiling panels may not protect passengers in a crash.

    Product
    STARCRAFT BUS — STARCRAFT BUS PRODIGY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-04072023-01·2023-04-07

    Russ' Commissary Fresh Salads Recalled Due to Possible Listeria Contamination

    The USDA FSIS issued a public health alert recalling fresh salads with chicken and ham containing lettuce due to possible Listeria monocytogenes contamination.

    Product
    Russ' Commissary — FSIS Issues Public Health Alert for Fresh Salads With Chicken and Ham Containing Lettuce Recalled by FDA for Possible Listeria Monocytogenes Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V245000·2023-04-06

    Prevost Recalls 2023 X3-45 Motor Coaches Due to Electrical Fire Risk

    Prevost is recalling 2023 X3-45 and X3-45 VIP motor coaches because an insufficient grommet allows electrical cables to chafe, potentially causing a short circuit and fire.

    Product
    PREVOST — PREVOST X3-45 VIP, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23174·2023-04-06

    Mammut Avalanche Shovels Recalled for Spring Locking Mechanism Failure

    Mammut Sports Group is recalling Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels because the spring locking mechanism can fail during emergency excavation, posing risk of injury or death.

    Product
    Alugator Ride 3.0 Hoe and Alugator Ride SE avalanche shovels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V253000·2023-04-06

    2023 BMW X5 Head Restraints May Fail in Crash

    BMW is recalling approximately 235 certain 2023 X5 vehicles with defective second-row head restraints that may not properly restrain occupants during a crash, violating federal safety standards.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V246000·2023-04-06

    Prevost Recalls 2023 X3-45 VIP Motor Coaches Due to Fire Risk

    Prevost is recalling 2023 X3-45 VIP motor coaches because a missing grommet allows electrical cables to chafe, potentially causing a short circuit and fire.

    Product
    PREVOST — PREVOST X3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V248000·2023-04-06

    Navistar Recalls International Buses Due to HVAC Wiring Fire Risk

    Navistar is recalling 2016-2020 International and IC Bus models because an HVAC wiring terminal may overheat, increasing the risk of a fire.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS DURASTAR, WORKSTAR, HC, PROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V252000·2023-04-06

    2022–2023 Land Rover Range Rover Seat Frame Defect Recall

    Jaguar Land Rover North America is recalling certain 2022–2023 Land Rover Range Rover vehicles because the second-row left seat frame may have been insufficiently welded and may not adequately secure occupants during crashes or sudden braking.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23175·2023-04-06

    IKEA Recalls BLÅVINGAD Fishing Games Due to Choking Hazard

    IKEA is recalling about 25,000 BLÅVINGAD fishing games because a small metal rivet in a wooden play piece can come loose and pose a choking hazard to young children. Four incidents have been reported globally, with none in the U.S. requiring medical attention.

    Product
    BLÅVINGAD fishing games
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23742·2023-04-06

    Monti Kids Basket with Balls Toys Recalled for Choking Hazard

    Monti Kids is recalling Basket with Balls toys sold in subscription boxes because the blue crocheted ball's sewn swirls can separate and expose small parts, creating a choking hazard for young children.

    Product
    Basket with Balls toys sold with Monti Kids Tummy-Time, 4-6M Play and Early Gross Motor subscription boxes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23176·2023-04-06

    BISSELL Cordless Wet Dry Vacuums Recalled for Fire Hazard

    BISSELL is recalling about 2,000 Cordless Multi-Surface Wet Dry Vacuums (models 2551R and 25518) because the battery pack circuit board can overheat and smoke, creating a fire hazard. No injuries have been reported.

    Product
    BISSELL® Cordless Multi-Surface Wet Dry Vacuums Models 2551R and 25518
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V242000·2023-04-05

    Maserati Recalls 2023 MC20 Cielo for Windshield Frame Bonding Defect

    Maserati is recalling 2023 MC20 Cielo vehicles because insufficient windshield frame bonding could allow the frame to detach in a crash, increasing injury risk.

    Product
    MASERATI — MASERATI MC20 CIELO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0686-2023·2023-04-05

    ISH Shrimpish Sample Meal Kit Recalled for Undeclared Soy Protein

    THE ISH COMPANY is recalling 355 ISH Shrimpish Sample Meal Kits distributed to multiple states throughout 2022 for undeclared soy protein that may cause allergic reactions in sensitive consumers.

    Product
    ISH Shrimpish Sample Meal Kit: ( Sample Meal Kit ) a package containing two ISH Foods plant-based Shrimpish products and several additional meal components. Each kit is shipped frozen, using styrofoam and dry ice. Affected components: ¿ Broth Plastic jar with lid ¿ XO Sauce
    Category
    Food
    Distribution
    36 states
  • SevereNHTSA·23V243000·2023-04-05

    New Flyer Recalls 2023 XD60 and XDE60 Buses for ABS Failure

    New Flyer is recalling 2023 XD60 and XDE60 buses because the anti-lock brake system may lose power during hard braking, increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XD60, XDE60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0651-2023·2023-04-05

    Enoki Mushrooms Recalled Due to Listeria monocytogenes Contamination

    SSS brand and K-Fresh branded enoki mushrooms are being recalled due to potential Listeria monocytogenes contamination. Consumers should not consume the affected product.

    Product
    SSS brand and K-Fresh branded Enoki Mushrooms Packaged in clear plastic 200g container
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V240000·2023-04-05

    MCI Recalls 2019-2021 Coaches Due to Obstructed Rear Lighting

    Motor Coach Industries is recalling 2019-2021 J4500, D45CRTLE, and J3500 coaches because rear lighting may be obstructed by bike racks, increasing crash risk.

    Product
    MCI — MCI D45CRTLE, J4500, J3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0674-2023·2023-04-05

    Seasoned Radish Sliced Recalled for Undeclared Fish, Shrimp, and Sesame

    Lemonland Food Corp is recalling Seasoned Radish Sliced products distributed in Washington due to undeclared Fish, Crustacean, and Sesame allergens. Consumers with these allergies should not consume this product.

    Product
    Seasoned Radish Sliced distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1286-2023·2023-04-05

    CRP Immunoturbidimetric Reagent Recalled for Positive Bias in Patient Samples

    Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.

    Product
    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0672-2023·2023-04-05

    Seasoned Garlic Stem Recalled Due to Undeclared Fish and Sesame Allergens

    Lemonland Food Corp recalled Seasoned Garlic Stem products due to undeclared fish (anchovy) and sesame allergens. Affected products were distributed in Washington from February 16-23, 2023.

    Product
    Seasoned Garlic Stem distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0669-2023·2023-04-05

    Perilla Leaves in Soybean Paste recalled for undeclared allergens

    Lemonland Food Corp recalls Perilla Leaves in Soybean Paste for undeclared soybean, wheat, fish, and shrimp allergens. Consumers with these allergies should avoid the product.

    Product
    Perilla Leaves in Soybean Paste distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0670-2023·2023-04-05

    Seasoned Peanut Recalled Due to Undeclared Peanut, Soybean, Wheat, and Sesame

    Lemonland Food Corp is recalling Seasoned Peanut distributed in Washington due to undeclared allergens including peanut, soybean, wheat, and sesame seeds. Containers were labeled at H-mart, G-mart, and M2M retail stores.

    Product
    Seasoned Peanut distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1310-2023·2023-04-05

    Iradimed MRidium MRI Infusion Pump Syringe Adapter Sets Recalled for Occlusion Risk

    Iradimed is recalling MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets due to a defective part that can limit venting function and cause occlusion, potentially interrupting medication delivery.

    Product
    Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0688-2023·2023-04-05

    Danncy Vainilla Pure Mexican Vanilla Extract Contains Prohibited Coumarin

    Danncy Vainilla Pure Mexican Vanilla Extract is being recalled because the product contains coumarin, a prohibited substance. Consumers should stop using the product.

    Product
    Danncy Vainilla Pure Mexican Vanilla Extract Clear Gluten Free Produced by Juan Miguel Anzaldua Gutierrez NET 33.8 FL OZ (1.0L) UPC 7503000781137 packaged in clear plastic bottles and Danncy Vainilla Pure Mexican Vanilla Extract Gluten Free Produced by Juan Miguel Anzaldua Gutier
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0683-2023·2023-04-05

    Seasoned Seaweed Recalled for Undeclared Sesame and Wheat Allergens

    Lemonland Food Corp is recalling Seasoned Seaweed distributed in Washington due to undeclared sesame seeds and wheat. Consumers with these allergies should not consume the product.

    Product
    Seasoned Seaweed distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0659-2023·2023-04-05

    Spicy Cucumber Salad recalled for undeclared sesame, fish, and wheat allergens

    Lemonland Food Corp recalls Spicy Cucumber Salad due to undeclared sesame seeds, fish (anchovy), and wheat allergens. The product was distributed in multiple container sizes in Washington.

    Product
    Spicy Cucumber Salad distributed in un-labeled plastic containers 8oz, 12oz. and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1302-2023·2023-04-05

    Chest Drain Valve Recalled for Insufficient Safety Instructions

    The Atrium Pneumostat Chest Drain Valve has been recalled because its instructions lack sufficient precautions against improper drainage and use outside healthcare settings.

    Product
    Atrium Pneumostat Chest Drain Valve, Part Number 16100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0656-2023·2023-04-05

    Seasoned Radish Recall Due to Undeclared Fish and Wheat Allergens

    Lemonland Food Corp recalls Seasoned Radish (Shredded) distributed in Washington due to undeclared fish (anchovy) and wheat allergens. The product was sold in 8oz, 12oz, and 16oz containers at H-Mart, G-Mart, and M2M stores.

    Product
    Seasoned Radish (Shredded) distributed in un-labeled plastic containers 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0662-2023·2023-04-05

    Seasoned Korean Lettuce Recalled for Undeclared Fish Allergen

    Lemonland Food Corp recalled Seasoned Korean Lettuce distributed in Washington due to undeclared fish (anchovy). Consumers with fish allergies should not consume this product.

    Product
    Seasoned Korean Lettuce distributed in un-labeled plastic containers 6oz or 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0533-2023·2023-04-05

    Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity

    Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2023·2023-04-05

    Surgical navigation system recalled for potential mechanical instability

    Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.

    Product
    Cirq Arm System 2.0
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0677-2023·2023-04-05

    Seasoned Fish Meat Recalled for Undeclared Fish, Wheat, and Soy Allergens

    Lemonland Food Corp is recalling Seasoned Fish Meat distributed in Washington due to undeclared fish, wheat, and soy allergens that could affect consumers with these allergies.

    Product
    Seasoned Fish Meat distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1309-2023·2023-04-05

    Leksell Stereotactic System Recall: Incorrect Instructions Distributed with Devices

    Elekta Instrument AB is recalling 70 Leksell Stereotactic System neurosurgical devices due to incorrect Instructions for Use being distributed with the devices. Incorrect documentation for neurosurgical equipment could impact proper device use.

    Product
    Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0479-2023·2023-04-05

    Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations

    Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.

    Product
    Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0689-2023·2023-04-05

    Mary's Gone Crackers recalled for potential foreign material contamination

    Mary's Gone Crackers Super Seed Seaweed & Black Sesame Crackers may contain foreign material. Approximately 2,376 cases were distributed throughout the USA.

    Product
    Mary s Gone Crackers Super Seed Seaweed & Black Sesame Crackers Product Item number: 10033380101 UPC: 8 53665 00510 7
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1318-2023·2023-04-05

    Covidien Shiley Lo-Pro Tracheal Tube Cuffed Recalled for Potential Inflation System Leaks

    Covidien is recalling Shiley Lo-Pro Oral/Nasal Tracheal Tubes due to potential leaks in the inflation system. The affected devices, used during anesthesia and procedures, may not maintain proper airway sealing.

    Product
    COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or other short-term procedures.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Food)·F-0655-2023·2023-04-05

    Seasoned Pollack Roe Recalled for Undeclared Fish Allergen

    Lemonland Food Corp is recalling Seasoned Pollack Roe due to undeclared fish allergen. The product was distributed in Washington from February 16-23, 2023.

    Product
    Seasoned Pollack Roe distributed in un-labeled plastic containers 6oz and 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0664-2023·2023-04-05

    Seasoned Vegetables Recalled for Undeclared Soy and Wheat Allergens

    Lemonland Food Corp is recalling Seasoned Vegetables (Cirsium Setidens) distributed in Washington due to undeclared soy and wheat allergens. Consumers with soy or wheat allergies should not consume this product.

    Product
    Seasoned Vegetables (Cirsium Setidens) distributed in un-labeled plastic containers 6oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0684-2023·2023-04-05

    Canned Geisha Medium Shrimp Recalled for Leaking Containers

    Kawasho Foods USA is recalling Geisha Medium Shrimp 4 oz cans due to leaking and bulging containers. The defect may compromise food safety.

    Product
    Geisha Medium Shrimp; WT 4OZ(113g)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0678-2023·2023-04-05

    Seasoned Lotus Root Recalled for Undeclared Soybean and Wheat

    Lemonland Food Corp recalled Seasoned Lotus Root for containing undeclared soybean and wheat allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Seasoned Lotus Root distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0661-2023·2023-04-05

    Seasoned Nut Recalled for Undeclared Peanut and Walnut Allergens

    Lemonland Food Corp recalled seasoned nut products for undeclared peanut and walnut allergens. Consumers with allergies to these nuts should not consume affected products sold in Washington between February 16-23, 2023.

    Product
    Seasoned Nut distributed in un-labeled plastic containers 6oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0667-2023·2023-04-05

    Seasoned Perilla Leaves Recalled Due to Undeclared Allergens

    Lemonland Food Corp recalled Seasoned Perilla Leaves in 6oz, 8oz, and 12oz containers distributed in Washington because the product contains undeclared allergens: sesame, soy, wheat, fish, and shrimp.

    Product
    Seasoned Perilla Leaves distributed in un-labeled plastic containers 6oz, 8oz, and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0657-2023·2023-04-05

    Radish Kimchi recalled for undeclared fish and shellfish allergens

    Lemonland Food Corp has recalled Radish Kimchi distributed in Washington due to undeclared fish (anchovy, sardinella) and shrimp. Consumers with allergies to fish or shellfish should not consume this product.

    Product
    Radish Kimchi distributed in un-labeled plastic containers 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0668-2023·2023-04-05

    Seasoned Vegetable Recalled for Undeclared Wheat, Fish, and Sesame

    Lemonland Food Corp recalled Seasoned Vegetable (Deodeok) distributed in Washington due to undeclared allergens: wheat, fish (anchovy), and sesame seeds. Consumers with allergies to these ingredients should not consume the product.

    Product
    Seasoned Vegetable (Deodeok) distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0681-2023·2023-04-05

    Seasoned Green Laver Recalled for Undeclared Soy, Wheat, Fish, and Sesame

    Lemonland Food Corp is recalling Seasoned Green Laver sold in Washington due to undeclared allergens including soybean, wheat, fish (anchovy), and sesame seeds. Consumers with allergies to these ingredients should not consume this product.

    Product
    Seasoned Green Laver distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0685-2023·2023-04-05

    Stainless Steel Water Bottles Recalled for Lead Leaching from Welded Screw Cap

    BINDLE BOTTLE is recalling Stainless Steel Water Bottles because the cup's screw cap is attached by a weld that leaches lead into drinking water.

    Product
    Stainless Steel Water Bottle The product comes in four sizes: 32 oz., 24 oz., 20 oz., and 13 oz.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0663-2023·2023-04-05

    Seasoned Hot Pepper Leaves recalled for undeclared fish and sesame allergens

    Lemonland Food Corp recalls Seasoned Hot Pepper Leaves from Washington due to undeclared Fish (Anchovy) and Sesame Seeds allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Seasoned Hot Pepper Leaves distributed in un-labeled plastic containers 8oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0680-2023·2023-04-05

    Stir-Fried Dried Squid Recalled for Undeclared Milk, Wheat, and Soybean

    Lemonland Food Corp recalled Stir-Fried Dried Squid distributed in Washington for undeclared Milk, Wheat, and Soybean allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Stir-Fried Dried Squid distributed in un-labeled plastic containers 6oz., 8oz., and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0475-2023·2023-04-05

    Calcitonin Salmon Nasal Spray Recalled for Out-of-Specification Impurities and Low Potency

    Endo Pharmaceuticals is recalling Calcitonin Salmon Nasal Spray due to out-of-specification impurities and subpotent drug content. Affected lots distributed nationwide have expiration dates ranging from March 2023 to March 2025.

    Product
    CALCITONIN SALMON — CALCITONIN SALMON (CALCITONIN SALMON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0481-2023·2023-04-05

    FDA Recalls Glimepiride Tablets Due to Manufacturing Quality Violations

    Direct Rx is voluntarily recalling Glimepiride 2 mg tablets nationwide due to manufacturing practice violations. The recall affects multiple lot numbers of 30-count and 90-count bottles distributed across the United States.

    Product
    Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2023·2023-04-05

    Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity

    Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0487-2023·2023-04-05

    Apollo Care Fentanyl and Ropivacaine Epidural Injection Recalled for Contamination

    Apollo Care is recalling 215 bags of Fentanyl and Ropivacaine epidural injection (Lot AC-016581) due to suspected microbial growth on external packaging. The recall affects product distributed in Missouri.

    Product
    Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1311-2023·2023-04-05

    Fluoroscopic X-Ray System Recalled for Unintended Table Movement Risk

    Siemens ARTIS pheno X-ray systems may experience unintended table movement that the system fails to detect, risking injury to patients, staff, or operators. The FDA is recalling 141 affected units nationwide.

    Product
    ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2023·2023-04-05

    FDA recalls ACL ELITE refurbished analyzer to remove Anti-Xa test

    Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.

    Product
    ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2023·2023-04-05

    Dental Implant Titanium Base Recalled for Stability and Fracture Risk

    Preat Corp is recalling Neodent GM X 6mm titanium base components due to a dimensional defect causing vertical movement. This instability may lead to abutment fracture and potential ingestion of dental materials by patients.

    Product
    Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2023·2023-04-05

    Defibtech DDU-100 Lifeline AED Recalled for Untested Component Risk

    Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.

    Product
    DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2023·2023-04-05

    Irvine Scientific embryo culture oil recalled due to detected toxicity

    Fujifilm Irvine Scientific is recalling its Oil for Embryo Culture product due to detection of oil toxicity in several manufacturing lots. A total of 15,131 bottles are affected.

    Product
    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1291-2023·2023-04-05

    Alcon Custom Pak Surgical Procedure Packs Recalled for Incomplete Seals

    Alcon Research is recalling 1,035 Custom Pak Surgical Procedure Packs with incomplete seals that affect sterility. These packs were distributed to surgical facilities in 14 US states.

    Product
    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 1913
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1293-2023·2023-04-05

    Surgical Robot Instrument Carriage Loose Due to Manufacturing Defect

    Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.

    Product
    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1303-2023·2023-04-05

    Express Mini 500 Chest Drain Recalled for Inadequate Instructions

    The Express Mini 500 Dry Seal Chest Drain has been recalled because its instructions do not adequately warn against draining it for continued use or using it outside healthcare settings. Approximately 8,184 cases were distributed worldwide.

    Product
    Express Mini 500 Dry Seal Chest Drain, Part Number 16400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2023·2023-04-05

    PCRopsis Reagent RVD-RT in vitro diagnostic kit recall for misleading labels

    Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT diagnostic kits due to misleading label statements that could affect proper use and test interpretation.

    Product
    PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2023·2023-04-05

    Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

    Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.

    Product
    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135;
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1304-2023·2023-04-05

    ACL Elite Analyzer HemosIL Liquid Anti-Xa test definition removal

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.

    Product
    ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2023·2023-04-05

    CoCr Femoral Head hip implant compatibility removed due to motion limitations

    Zimmer is updating the compatibility matrix for the CoCr Femoral Head XS hip implant to remove pairing with Epsilon Durasul Constrained Acetabular Liners due to insufficient range of motion in flexion/extension.

    Product
    CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0676-2023·2023-04-05

    Seasoned Crab Products Recalled by Lemonland for Undeclared Allergens

    Lemonland Food Corp recalls seasoned crab sold in Washington due to undeclared allergens including crab, sesame seeds, and anchovy. Consumers with allergies to these ingredients should not consume this product.

    Product
    Seasoned Crab was distributed in un-labeled plastic containers 8oz. and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0660-2023·2023-04-05

    Perilla Leaves in Soy Sauce Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Perilla Leaves in Soy Sauce distributed in Washington due to undeclared Wheat, Soybean, and Fish (Anchovy). The product was sold in 12oz containers at H-mart, G-mart, and M2M retail stores.

    Product
    Perilla Leaves in Soy Sauce distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1290-2023·2023-04-05

    GaGa Pro Class IV Laser Projectors Recalled for FDA Compliance Failure

    GaGa Pro Lighting Equipment Co. manufactures Class IV Laser Light Show projectors that are being recalled due to non-compliance with FDA's Performance Standard for laser products. Eleven units distributed nationwide are affected.

    Product
    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2023·2023-04-05

    Baxter Automated Peritoneal Dialysis System Electrical Safety Testing Failure

    Baxter Healthcare Corporation is recalling 16 Automated Peritoneal Dialysis Systems due to incomplete electrical safety testing. Affected devices require additional testing.

    Product
    Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0652-2023·2023-04-05

    Rold Gold Original Tiny Twists Pretzels Recalled for Undeclared Soy

    Frito-Lay is recalling Rold Gold Original Classic Tiny Twists Pretzels because the product contains undeclared soy lecithin, which may affect consumers with soy allergies.

    Product
    Rold Gold Original Classic Tiny Twists Pretzels in 16oz UPC 2840004768 packaged in a flexible bag
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0682-2023·2023-04-05

    Hot Pepper in Soy Sauce Recalled for Undeclared Soy and Wheat

    Lemonland Food Corp recalled Hot Pepper in Soy Sauce distributed in 12-ounce containers due to undeclared soybean and wheat allergens. Consumers with soy or wheat allergies should not consume this product.

    Product
    Hot Pepper in Soy Sauce distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0687-2023·2023-04-05

    Almost Famous Popcorn Poppy Chow recalled for undeclared peanut allergen

    Rieckhoff Family Businesses is recalling Almost Famous Popcorn Poppy Chow because peanuts are listed in ingredients but omitted from the allergen statement. Consumers with peanut allergies may be at serious risk.

    Product
    Almost Famous Popcorn Poppy Chow, 9.9 oz bag (UPC 8 5001151513)
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0675-2023·2023-04-05

    Seasoned Dried Pollack Recalled for Undeclared Allergens

    Lemonland Food Corp is recalling Seasoned Dried Pollack distributed in Washington for undeclared Fish, Wheat, and Soybean allergens. Consumers with these allergies should not consume this product.

    Product
    Seasoned Dried Pollack distributed in un-labeled plastic containers 6oz., 8 oz., and 12 oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0665-2023·2023-04-05

    Stir-Fried Kimchi Recalled for Undeclared Allergens: Fish, Shrimp, Wheat, Sesame

    Lemonland Food Corp recalls 12 oz. containers of Stir-Fried Kimchi distributed in Washington due to undeclared allergens: fish (anchovy), shrimp, wheat, and sesame. Consumers with allergies to these ingredients should not consume this product.

    Product
    Stir-Fried Kimchi distributed in un-labeled plastic containers 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0653-2023·2023-04-05

    Seasoned Pickled Radish Recalled for Undeclared Wheat and Sesame Allergens

    Lemonland Food Corp is recalling Seasoned Pickled Radish sold in Washington due to undeclared wheat and sesame allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Seasoned Pickled Radish distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0673-2023·2023-04-05

    Wild Leek Recalled for Undeclared Soy, Wheat, and Fish Allergens

    Lemonland Food Corp is recalling Wild Leek sold in Washington due to undeclared allergens: soybean, wheat, and fish (anchovy). Consumers with allergies to these ingredients should avoid this product.

    Product
    Wild Leek distributed in un-labeled plastic containers 8oz and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0658-2023·2023-04-05

    Stir-Fried Fish Cake Recalled Due to Undeclared Allergens

    Lemonland Food Corp recalled stir-fried fish cake due to undeclared soybean, wheat, fish, and sesame allergens. The affected products were distributed in Washington from February 16 to 23, 2023.

    Product
    Stir-Fried Fish Cake distributed in un-labeled plastic containers 6oz, 8oz, 12oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0654-2023·2023-04-05

    Stir-Fried Anchovy recalled for undeclared wheat, soybean, fish, and sesame

    Lemonland Food Corp has recalled Stir-Fried Anchovy products distributed in Washington due to undeclared allergens: wheat, soybean, fish, and sesame. Consumers with allergies to these ingredients should not consume the product.

    Product
    Stir-Fried Anchovy distributed in un-labeled plastic containers 6oz, 8oz, and 16oz. Containers were then labeled at H-mart, G-mart, or M2M retail stores.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1308-2023·2023-04-05

    MicroVue C1-Inhibitor Plus EIA kits recalled for potential test failure

    Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.

    Product
    MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1305-2023·2023-04-05

    ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed

    Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.

    Product
    ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2023·2023-04-05

    Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations

    Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.

    Product
    Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2023·2023-04-05

    Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations

    Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.

    Product
    Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2023·2023-04-05

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.

    Product
    Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2023·2023-04-05

    Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations

    Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.

    Product
    Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1296-2023·2023-04-05

    PCRopsis Reagent Buccal Kit Recalled for Misleading Label Statements

    Entopsis, Inc. is recalling PCRopsis Reagent Buccal (REF 282001), an extraction-free PCR reagent kit, due to misleading label statements on the product labeling.

    Product
    PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0671-2023·2023-04-05

    Rakkyo (scallions) recalled due to incorrect ingredients statement

    Lemonland Food Corp recalled Rakkyo (scallions) distributed in Washington because the ingredients statement label required correction. The product contains no allergens.

    Product
    Rakkyo (scallions) distributed in un-labeled plastic containers 8oz and/or 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0666-2023·2023-04-05

    Seasoned Garlic with Salt and Vinegar recalled for ingredient statement update

    Lemonland Food Corp recalled seasoned garlic distributed in Washington after providing consignees with an updated ingredients statement.

    Product
    Seasoned Garlic with Salt and Vinegar distributed in un-labeled plastic containers 6oz, 8oz, and 12oz. Containers were then labeled at H-mart, G-mart, or M2M retail store.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1298-2023·2023-04-05

    Medical device lysis beads recalled for misleading label statements

    Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.

    Product
    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1299-2023·2023-04-05

    PCR Reagent Recalled for Misleading Label Statements

    Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.

    Product
    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1297-2023·2023-04-05

    PCRopsis Activator nucleic acid extraction kits recalled for misleading labels

    Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The products were distributed nationwide and internationally.

    Product
    PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2023·2023-04-05

    Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations

    Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.

    Product
    Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2023·2023-04-05

    PCRopsis Support Medical Device Recall Due to Misleading Label Statements

    Entopsis, Inc. is recalling PCRopsis Support nucleic acid extraction reagents due to misleading statements on product labels. No illnesses or injuries have been reported.

    Product
    PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2023·2023-04-05

    PCRopsis BCSNano nucleic acid extraction kit recalled for misleading label statements

    Entopsis, Inc. is recalling PCRopsis BCSNano nucleic acid extraction kits due to misleading statements on the product label. The affected lot (Lot 3, expiring 11/2023) was distributed nationwide and internationally.

    Product
    PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2023·2023-04-05

    Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.

    Product
    Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide

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