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.

201–300 of 411

  • HighNHTSA·23V262000·2023-04-13

    Travel Trailer Solar Panels May Detach Due to Loose Hardware

    Forest River is recalling approximately 2,616 travel trailers due to solar panel mounting hardware that may become loose and detach, increasing the risk of a crash during transit.

    Product
    COACHMEN — COACHMEN, SHASTA, EAST TO WEST CHAPARRAL, SPIRIT, PHOENIX, TANDARA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V264000·2023-04-13

    Ram 1500 Recalled for Missing B-Pillar Impact Sensors

    Chrysler is recalling 2022 Ram 1500 vehicles because missing B-pillar impact sensors may prevent air bags from deploying in a crash.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V268000·2023-04-13

    Nissan Rogue Driver Seat Weld Safety Defect Recall

    The driver's powered seat may not be fully secured due to weld defects in the seat frame, potentially failing to properly restrain occupants during a crash. Nissan will inspect and replace affected seat components at no cost.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER, QX60, ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E032000·2023-04-13

    Chrysler Recalls Diesel Fuel Pumps Due to Engine Stall Risk

    Chrysler is recalling specific Mopar high-pressure fuel pumps and 3.0L diesel engines because pump failure can cause engine stalls, increasing crash risk.

    Product
    FUEL SYSTEM, DIESEL:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23743·2023-04-13

    Arshiner Children's Nightgowns Recalled for Flammability Standard Violations

    Arshiner children's nightgowns sold on Amazon from July 2020 through March 2022 fail to meet federal flammability standards for sleepwear, posing a burn hazard to children. Consumers should stop using them immediately and contact Arshiner for a refund.

    Product
    Arshiner Children's Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23744·2023-04-13

    FunnyPaja Children's Bathrobes Recalled for Flammability Hazard

    FunnyPaja children's bathrobes fail to meet federal flammability standards for sleepwear, posing a burn risk. About 4,500 units sold on Amazon from December 2020 through May 2022 are affected.

    Product
    FunnyPaja Children's Bathrobes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23178·2023-04-13

    Moen Flo Smart Water Monitor Battery Back-Ups Recalled for Fire Hazard

    Moen has recalled about 10,000 Flo Smart Water Monitor Lithium-Ion Battery Back-Ups because the batteries can overheat and catch fire. Three reports of overheating and fire have been received, with minor property damage reported but no injuries.

    Product
    Flo Smart Water Monitor Lithium-Ion Battery Back-Ups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0692-2023·2023-04-12

    Sysco Imperial Caesar Dressing Recalled for Egg Allergen Labeling Discrepancy

    Sysco Imperial Caesar Dressing recalled due to labeling discrepancy. The outer case label indicates the product contains eggs, but the primary product label does not list eggs as an ingredient.

    Product
    Sysco Imperial Caesar Dressing NET CONTENTS 1 GAL (3.78 l) INGREDIENTS: Soybean Oil, Water, Distilled Vinegar, Parmesan Cheese***High Fructose Corn Syrup, Salt, Contains less than 2% of Ground Mustard, Spice, Dried Garlic, Anchovy Paste***Sodium Benzoate***Calcium Disodium EDTA**
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1275-2023·2023-04-12

    FreeStyle Libre Reader batteries pose fire and swelling hazard

    FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.

    Product
    FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1288-2023·2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0691-2023·2023-04-12

    Peanut Butter Pie Recalled Due to Potential Salmonella Contamination

    Desserts by Helen, Inc. is recalling Peanut Butter Pie due to potential contamination from JIF peanut butter manufactured during a recall period in 2022. The recall affects products distributed in Indiana, Kentucky, and Ohio.

    Product
    Peanut Butter Pie, 1 count
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1287-2023·2023-04-12

    Portable Electric Ventilators May Deliver Insufficient Oxygen During High-Concentration Therapy

    Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen to patients.

    Product
    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1322-2023·2023-04-12

    Philips DreamStation respiratory devices recalled for communication issues affecting prescription settings

    Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.

    Product
    Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14. Used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0732-2023·2023-04-12

    Gerber GoodStart SoothePro infant formula recalled due to possible Cronobacter contamination

    Perrigo Nutritionals is recalling Gerber GoodStart SoothePro infant formula due to potential Cronobacter contamination. The recall affects 182,888 cans distributed nationwide and in Canada.

    Product
    Gerber GoodStart SoothePro Infant Formula with Iron. Milk Based Powder. Stage 1, 0 - 12 Months. Nestle Infant Nutrition, Arlington, VA 22209. Packaged in the following sizes: 1. Net Wt 12.4 oz. (351 g) (6 cans per case) UPC 050000-62400 3 2. Net Wt 30.6 oz. (1.91 lb /
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2023·2023-04-12

    FreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard

    Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.

    Product
    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1289-2023·2023-04-12

    Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery

    Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.

    Product
    Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0697-2023·2023-04-12

    Clio Strawberry Granola & Yogurt Parfait Bars Recalled Due to Listeria Risk

    Clio Strawberry Granola & Yogurt Parfait Bars (UPC 854021008152) are being recalled due to possible Listeria contamination. Affected products were distributed to retail stores in Iowa, Illinois, Virginia, Wisconsin, and North Carolina.

    Product
    Clio Strawberry Granola & Yogurt Parfait Bar Net Wt. 1.94 OZ (55g ) UPC: 854021008152 Packaged in a cardboard box.
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1273-2023·2023-04-12

    FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard

    FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.

    Product
    FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2023·2023-04-12

    Endoscopic vessel harvesting system recalled for sterilization defect

    900 units of Maquet Cardiovascular's VASOVIEW HEMOPRO endoscopic vessel harvesting system are being recalled because some batches were not sterilized to their minimum specification, creating a potential infection risk for surgical patients.

    Product
    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2023·2023-04-12

    Medtronic Grafton Putty Bone Matrix Packaging Sterile Barrier Non-Conformance

    Medtronic recalls 186,889 units of Grafton Putty demineralized bone matrix product due to potential packaging defects that could compromise sterile barrier integrity. No illnesses reported.

    Product
    Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2023·2023-04-12

    Medtronic Grafton Plus Paste surgical implant recall due to packaging defects

    Medtronic is recalling 37,721 units of Grafton Plus Paste surgical implant material due to potential packaging defects in the sterile pouch system that could compromise sterile barrier integrity.

    Product
    Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T4500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0494-2023·2023-04-12

    Ropinirole 0.5 mg tablets recalled for manufacturing quality deviations

    RemedyRepack Inc. is recalling 17 bottles of Ropinirole 0.5 mg tablets due to manufacturing process deviations. The product was distributed nationwide within the United States.

    Product
    Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0523-2023·2023-04-12

    Simvastatin Tablets, USP, 80 mg Recalled Due to Manufacturing Deviations

    Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg due to manufacturing quality control deviations identified at Accord Healthcare during FDA inspection. Approximately 57 bottles distributed nationwide.

    Product
    Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2023·2023-04-12

    Medtronic Grafton Gel Surgical Implant Sterile Barrier Packaging Recall

    Medtronic is recalling Grafton Gel demineralized bone matrix surgical implants due to packaging non-conformances in the sterile pouch that could compromise the sterile barrier of the implant.

    Product
    Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120IN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0521-2023·2023-04-12

    Pravastatin Sodium Tablets Recalled Due to Manufacturing Deviations

    Preferred Pharmaceuticals is recalling Pravastatin Sodium 20 mg tablets nationwide due to manufacturing practice deviations identified during FDA inspection. No illnesses have been reported.

    Product
    Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0518-2023·2023-04-12

    Montelukast Sodium Tablets Recalled for Manufacturing Deviations

    Preferred Pharmaceuticals is recalling Montelukast Sodium Tablets, USP, 10 mg due to current Good Manufacturing Practice deviations discovered during an FDA inspection. The product was distributed nationwide.

    Product
    Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2023·2023-04-12

    Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances

    Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.

    Product
    Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V261000·2023-04-12

    2023 Honda CMX300 Motorcycle Crank Case Cover May Fall Off, Causing Oil Leak

    Honda is recalling certain 2023 CMX300 motorcycles. The right crank case cover was improperly painted and may fall out, allowing oil to leak onto the exhaust pipe or rear tire, risking fire or crash.

    Product
    HONDA — HONDA CMX300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V260000·2023-04-12

    2023 BMW X1 recalled for pinched rear seat belts

    BMW is recalling 2023 X1 models because rear seat belts may have been pinched during assembly, potentially preventing proper function in a crash. Dealers will inspect and adjust the trim panels at no charge.

    Product
    BMW — BMW X1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0525-2023·2023-04-12

    Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals is recalling Simvastatin 40 mg tablets nationwide due to manufacturing practice violations at the production facility. The recall is precautionary.

    Product
    Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2023·2023-04-12

    Medtronic Grafton Orthoblend Surgical Bone Graft Packaging Defect Recall

    Medtronic recalls Grafton Orthoblend bone graft products due to potential sterile packaging defects that could compromise product sterility. The packaging non-conformances may allow breach of the dual-barrier protection system.

    Product
    Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0507-2023·2023-04-12

    Alprazolam 0.5 mg tablets recalled due to manufacturing contamination

    Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.

    Product
    Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2023·2023-04-12

    CAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding

    Terumo Cardiovascular Systems is recalling 4,940 CAPIOX FX25 oxygenators because an arterial thermistor component may be improperly bonded to the oxygenator port, potentially causing leaks.

    Product
    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0690-2023·2023-04-12

    Astor Chocolate Wafer Sticks Recalled for Undeclared Cashew Allergen

    Eastland Food Corporation recalls Astor Chocolate Wafer Sticks because cashews are listed in ingredients but not declared in the allergen contains statement, posing a risk to consumers with cashew allergies.

    Product
    Astor Chocolate Wafer Stick NWT WT. 11.64 OZ 330g UPC 72375102886
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-1346-2023·2023-04-12

    Terumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding

    Terumo Cardiovascular is recalling CAPIOX NX19 oxygenators with improperly bonded arterial thermistors that may leak. Eighty-four units were distributed across the US and internationally.

    Product
    CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0695-2023·2023-04-12

    Shirakiku Furikake Seasoned Seaweed Flakes Recalled for Incorrect Crustacean Labeling

    Wismettac Asian Foods is recalling Shirakiku Furikake Seasoned Roasted Seaweed Flakes due to incorrect crustacean identification on the label. The product was distributed to 22 states.

    Product
    FURIKAKE SEASONED ROASTED SEAWEED FLAKES SEAFOOD Product number: 38245 Brand name: Shirakiku Distributed by: Wismettac Asian Foods, Inc. 13409 Orden Drive Santa Fe Springs, CA 90670
    Category
    Food
    Distribution
    22 states
  • HighFDA (Drugs)·D-0498-2023·2023-04-12

    Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations

    RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2023·2023-04-12

    Medtronic Grafton Flex bone graft products recalled for packaging integrity defects

    Medtronic is recalling Grafton Flex demineralized bone matrix products due to potential packaging non-conformances that could compromise sterile barrier integrity. Approximately 2,987 units were distributed worldwide.

    Product
    Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0694-2023·2023-04-12

    Purity Sweet Acidophilus 1% Low Fat Milk Recall Due to Sanitizer Contamination

    DFA Dairy Brands Fluid, LLC is recalling Purity Sweet Acidophilus 1% Low Fat Milk due to potential sanitizer contamination. The recalled product was distributed in Alabama.

    Product
    Purity Sweet Acidophilus 1% Lowfat Milk packaged in paper half pint cartons - 50 cartons per case, Keep Refrigerated
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0496-2023·2023-04-12

    Simvastatin 10 mg Tablets Recalled for Manufacturing Practice Deviations

    RemedyRepack Inc. voluntarily recalled Simvastatin 10 mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lots distributed to consignees throughout the United States.

    Product
    Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2023·2023-04-12

    Rosuvastatin Tablets Recalled Due to Manufacturing Deviations

    Preferred Pharmaceuticals is recalling 264 bottles of Rosuvastatin Tablets 5mg nationwide due to manufacturing deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0504-2023·2023-04-12

    Alprazolam 0.25mg tablets recalled for potential cross contamination

    Preferred Pharmaceuticals is recalling Alprazolam 0.25mg tablets (Lot G1822K, expiration 5/31/2023) nationwide due to potential cross contamination from manufacturing deviations. No illnesses have been reported.

    Product
    Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0506-2023·2023-04-12

    Alprazolam 1mg tablets recalled for manufacturing contamination risk

    Preferred Pharmaceuticals is recalling Alprazolam 1mg tablets due to manufacturing deviations that created a potential cross-contamination risk. Affected lots expire August 2024.

    Product
    Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0522-2023·2023-04-12

    Simvastatin Tablets Recalled Due to Manufacturing Compliance Deviations

    Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 10 mg due to manufacturing compliance deviations identified at Accord Healthcare. No illnesses or injuries have been reported.

    Product
    Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0513-2023·2023-04-12

    Clopidogrel Tablets 75 mg Recalled for Manufacturing Quality Deviations

    Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.

    Product
    Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0505-2023·2023-04-12

    Alprazolam 0.5mg Tablets Recalled Due to Potential Cross Contamination

    Preferred Pharmaceuticals is recalling Alprazolam 0.5mg tablets nationwide due to CGMP manufacturing deviations at Breckenridge Pharmaceuticals that created a potential cross-contamination risk.

    Product
    Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0492-2023·2023-04-12

    Doxazosin 2 mg tablets recalled for manufacturing practice deviations

    RemedyRepack Inc. is voluntarily recalling Doxazosin 2 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 30-count and 90-count bottles.

    Product
    Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0489-2023·2023-04-12

    Testosterone Cypionate Injection Recalled for Manufacturing Defect

    Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection due to complaints that crystals fail to redissolve after warming and shaking, a manufacturing quality defect affecting specific lots nationwide.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0501-2023·2023-04-12

    Rosuvastatin 10mg tablets recalled for manufacturing process deviations

    RemedyRepack Inc. is recalling Rosuvastatin 10mg tablets due to cGMP deviations in the manufacturing process. The recall affects 30-count and 90-count bottles distributed nationwide.

    Product
    Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2023·2023-04-12

    Stryker Tourniquet Cuff May Fail to Hold Pressure During Surgery

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or hold pressure during initial surgical setup. This failure could allow blood to flow from the surgical site, potentially causing hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2023·2023-04-12

    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure

    Maquet Cardiovascular is recalling approximately 2,300 units of the VASOVIEW HEMOPRO 2 system because some batches were not sterilized to specification. This sterilization failure creates a risk of contamination and potential infection during surgical procedures.

    Product
    VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2023·2023-04-12

    Medtronic Grafton DBF Inject bone matrix products recalled for packaging defects

    Medtronic is recalling Grafton DBF Inject demineralized bone matrix products due to potential packaging non-conformances that may compromise the sterile barrier. Over 10,000 units distributed worldwide are affected.

    Product
    Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2023·2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery

    Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2023·2023-04-12

    CooperSurgical embryo culture medium product substitution recall

    CooperSurgical is recalling Global Total LP embryo culture medium after discovering affected units may contain a different medium lacking the required protein source for embryo development.

    Product
    Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2023·2023-04-12

    Medtronic Grafton Matrix Bone Graft Packaging Sterility Concerns

    Medtronic is recalling Grafton Matrix bone graft products due to potential packaging defects that could compromise sterility. A total of 19,057 units were distributed worldwide.

    Product
    Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2023·2023-04-12

    Medtronic Grafton Crunch sterile pouch packaging non-conformance recall

    Medtronic is recalling Grafton Crunch demineralized bone matrix products due to potential packaging non-conformances that may compromise sterile barriers. 5,308 units are affected globally.

    Product
    Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2023·2023-04-12

    Moberg CNS-350 Neuromonitoring System Recalled for Battery Leakage Risk

    Moberg is recalling 89 CNS-350 Neuromonitoring System devices due to battery leakage that can corrode the metal enclosure, potentially causing skin injury. Affected units were distributed worldwide.

    Product
    Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2023·2023-04-12

    Stryker Color Cuff Tourniquet Cuff pressure failure recall

    Stryker is recalling 1,730 units of Color Cuff Non-Sterile Tourniquet Cuffs due to failures in achieving and maintaining pressure during setup, which could result in operative site blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2023·2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss

    Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1349-2023·2023-04-12

    Abbott Alinity m System Recall: Missing Components and Improper Calibration

    Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.

    Product
    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1345-2023·2023-04-12

    CAPIOX RX15 Oxygenator units recalled due to improper thermistor bonding

    Terumo is recalling CAPIOX RX15 Hollow Fiber Oxygenators due to improper bonding of the arterial thermistor, which may cause leaks at the connection port.

    Product
    CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2023·2023-04-12

    Medtronic Grafton Matrix surgical strips: potential sterile barrier packaging defects

    Medtronic is recalling Grafton Matrix Strips due to potential defects in the sterile packaging barrier. Non-conforming packaging could allow sterile barrier compromise in this surgical implant product.

    Product
    Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2023·2023-04-12

    Medtronic Grafton DBF Bone Matrix Sterile Packaging Barrier Defect Recall

    Medtronic is recalling Grafton DBF bone matrix products due to potential packaging defects in the dual-barrier sterile pouch system. The defects could lead to a breach in the sterile barrier.

    Product
    Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2023·2023-04-12

    Medtronic Accelerate Grafton DBF Bone Matrix Packaging Defect Recall

    Medtronic is recalling Accelerate Grafton DBF bone matrix products due to potential packaging non-conformances in the sterile pouch system that may compromise the sterile barrier. The recall affects 3,037 units distributed worldwide.

    Product
    Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Deminera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2023·2023-04-12

    Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure

    Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2023·2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1321-2023·2023-04-12

    Tempus Pro Patient Monitor power supplies recalled for fluid ingress and safety issues

    Remote Diagnostic Technologies is recalling 5,540 Tempus Pro Patient Monitors due to fluid ingress and basic safety issues identified with power supplies during internal testing.

    Product
    Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2023·2023-04-12

    Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations

    RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.

    Product
    Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2023·2023-04-12

    Doxazosin Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was distributed nationwide.

    Product
    Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2023·2023-04-12

    Montelukast Sodium Oral Granules Recalled for Failed Impurity Specifications

    Teva is recalling Montelukast Sodium Oral Granules 4 mg (lot 3007556A) due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.

    Product
    Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2023·2023-04-12

    Glimepiride Tablets Recall Due to Manufacturing Quality Deviations

    Preferred Pharmaceuticals is recalling Glimepiride Tablets 4 mg due to Current Good Manufacturing Practice (cGMP) deviations identified at the manufacturer, Accord Healthcare. The recall affects 15 bottles distributed nationwide.

    Product
    Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2023·2023-04-12

    Atorvastatin Calcium Tablets Recalled for Manufacturing Process Deviations

    Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets (10 mg) distributed nationwide due to manufacturing process deviations identified at Accord Healthcare. Affected lot numbers are A0523D, F14220, and J0622Q.

    Product
    Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0509-2023·2023-04-12

    Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination

    Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.

    Product
    Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2023·2023-04-12

    Cyanocobalamin injection vials recalled for failing potency tests

    Accord Healthcare recalled 4,574 cartons of Cyanocobalamin injection (Lot R2200394) nationwide after testing showed the drug was sub-potent and failed to meet strength specifications.

    Product
    Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Dur
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0512-2023·2023-04-12

    Atorvastatin Calcium Tablets 20 mg Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during FDA inspection.

    Product
    Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2023·2023-04-12

    Drug Recall: Simvastatin tablets due to manufacturing deviations

    RemedyRepack Inc. is recalling Simvastatin 40 mg tablets nationwide due to manufacturing deviations. The voluntary recall was initiated in March 2023.

    Product
    Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0491-2023·2023-04-12

    Drug Recall: Atorvastatin 10 mg tablets due to manufacturing process violations

    RemedyRepack Inc. is recalling specific lots of Atorvastatin 10 mg tablets distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated March 20, 2023.

    Product
    Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0524-2023·2023-04-12

    Simvastatin Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were distributed nationwide.

    Product
    Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2023·2023-04-12

    Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations

    RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.

    Product
    Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0497-2023·2023-04-12

    Drug Recall: Tadalafil 5 mg Tablets Due to Manufacturing Deviations

    RemedyRepack Inc. recalled Tadalafil 5 mg tablets due to cGMP manufacturing process deviations. The recall affected 16 bottles distributed nationwide; no illnesses have been reported.

    Product
    Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2023·2023-04-12

    Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.

    Product
    Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2023·2023-04-12

    Drug Recall: Rosuvastatin 5mg Tablets for Manufacturing Deviations

    RemedyRepack Inc. is recalling 399 bottles of Rosuvastatin 5mg tablets nationwide due to manufacturing deviations. No illnesses have been reported.

    Product
    Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2023·2023-04-12

    Finasteride Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.

    Product
    Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0493-2023·2023-04-12

    Glimepiride 2 mg Tablets Recalled for Manufacturing Quality Deviations

    RemedyRepack Inc. is recalling Glimepiride 2 mg tablets distributed nationwide due to manufacturing quality deviations (cGMP violations). The recall affects 220 bottles across multiple lot numbers.

    Product
    Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0499-2023·2023-04-12

    Ropinirole 2mg Tablets Recalled for Manufacturing Practice Deviations

    RemedyRepack Inc. is recalling Ropinirole 2mg tablets due to manufacturing practice deviations. No illnesses have been reported.

    Product
    Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0519-2023·2023-04-12

    Rosuvastatin Calcium Tablets Recalled for Manufacturing Deviations

    Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.

    Product
    ROSUVASTATIN CALCIUM — ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2023·2023-04-12

    Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns

    Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.

    Product
    Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2023·2023-04-12

    Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations

    RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.

    Product
    Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1319-2023·2023-04-12

    Biosense Webster Guiding Sheath Recalled for Carton Label Mismatch

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheaths are being recalled because the carton label does not match the inner pouch label. No illnesses or injuries have been reported.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2023·2023-04-12

    Glimepiride Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals recalls Glimepiride Tablets, 2 mg, 90-count bottles due to manufacturing process deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0526-2023·2023-04-12

    Prescription Tadalafil tablets recalled for manufacturing process deviations

    Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2023·2023-04-12

    Biosense Webster guiding sheath recalled for labeling mismatch

    Biosense Webster is recalling 316 units of Carto Vizigo guiding sheaths because the carton label does not match the inner sterile pouch label, potentially affecting product identification.

    Product
    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0696-2023·2023-04-12

    Shirakiku Furikake Seaweed Flakes Recalled for Incorrect Crustacean Labeling

    Wismettac Asian Foods is recalling Shirakiku Furikake Seasoned Roasted Seaweed Flakes Spicy due to incorrect crustacean labeling. The company distributed 17,517 packages across 22 states.

    Product
    FURIKAKE SEASONED ROASTED SEAWEED FLAKES SPICY Product #38246 Brand name: Shirakiku Distributed by: Wismettac Asian Foods, Inc. 13409 Orden Drive Santa Fe Springs, CA 90670
    Category
    Food
    Distribution
    22 states
  • SevereNHTSA·23E031000·2023-04-11

    Meritor Recalls Front Drive Steer Axles Due to Fastener Loosening

    Meritor is recalling specific front drive steer axles because fasteners may loosen, potentially causing axle separation and loss of vehicle control.

    Product
    STEERING:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V259000·2023-04-07

    Thomas Built Buses Recall 48 School Buses for Steering Defect

    Daimler Trucks North America is recalling 48 Thomas Built Buses school buses because a missing fastener may allow the steer arm to detach, risking loss of steering control.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2 JOULEY, SAF-T-LINER C2, SAF-T-LINER MVP-EF, HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V255000·2023-04-07

    Volvo VNR Trucks Recalled for Aggressive Adaptive Cruise Control Braking

    Volvo Trucks is recalling 2020-2023 VNR Electric vehicles equipped with Adaptive Cruise Control that can trigger aggressive braking under light load conditions, risking rear axle skidding and loss of vehicle control.

    Product
    VOLVO — VOLVO VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V257000·2023-04-07

    Buell Recalls 2021-2022 1190 RX and SX Motorcycles for Gear Shift Defect

    Buell Motorcycles is recalling 2021-2022 1190 RX and SX motorcycles because an improperly installed index spring may cause gear slipping or shifting failure, increasing crash risk.

    Product
    BUELL — BUELL 1190 RX HAMMERHEAD, 1190 SX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V207000·2023-04-07

    Lightning eMotors Recalls 148 Vehicles Due to Battery Pack Defects

    Lightning eMotors is recalling 148 electric vehicles because defective battery pack welds may cause internal leaks, leading to battery failure, loss of power, or fire.

    Product
    LIGHTNING EMOTORS — LIGHTNING EMOTORS FE4-129, FT3-86, FT3-43, FE4-86
    Category
    Vehicle
    Distribution
    Distributed nationwide

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