The Recall Desk

Archive

June 2023 recalls

513 recalls were announced in June 2023.

What the numbers show

Critical
13
Severe
177
High
265
Moderate
57
Low
1

Of the 513 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

301–400 of 513

  • HighFDA (Devices)·Z-1679-2023·2023-06-14

    DePuy Mitek surgical anchor inserter tip may fragment and be retained

    DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2023·2023-06-14

    SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter

    Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.

    Product
    SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1689-2023·2023-06-14

    TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size

    Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.

    Product
    The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1701-2023·2023-06-14

    HydroSil Go Catheters Recalled for Packaging Sterility Risk

    C.R. Bard Inc is recalling HydroSil Go Intermittent Urinary Catheters because the resealing label may separate from the foil pouch, potentially compromising product sterility. The recall affects 308,520 devices worldwide.

    Product
    HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1695-2023·2023-06-14

    ESR Diagnostic Control Vials Recalled for Incorrect Lot Labeling

    Mechatronics USA recalls approximately 10,752 units of ESR quality control vials due to incorrect lot labeling that causes instrument results to be falsely flagged as out of range.

    Product
    RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1694-2023·2023-06-14

    ESR Diagnostic Quality Control Material Incorrectly Labeled as Different Level

    RR Mechatronics Starrsed Control Level N ESR vials were mislabeled as a different control level, causing instruments to flag results as out of range. The mislabeling affects approximately 9,306 units worldwide.

    Product
    RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2023·2023-06-14

    Fluoride Varnish Packaging Error: Wrong Flavor Variant in White Mint Package

    Young Dental Manufacturing is recalling Benco Dental iris 5% fluoride varnish packages labeled White Mint because they may contain Bubblegum varnish instead. The recall affects 344 boxes distributed to Florida, Nevada, and Pennsylvania.

    Product
    BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0978-2023·2023-06-14

    Bacaolinita Liquid Dietary Supplement Recalled for Undeclared PEG-40 Ingredient

    Procaps is recalling Bacaolinita Liquid Dietary Supplement (8 fl oz bottles) because PEG-40 was not declared on the product label. Consumers should discontinue use.

    Product
    Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardboard box
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0869-2023·2023-06-14

    Buprenorphine Sublingual Tablets Recalled for Manufacturing Quality Deviations

    Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.

    Product
    BUPRENORPHINE — BUPRENORPHINE (BUPRENORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0870-2023·2023-06-14

    Glycopyrrolate Injection Vials Recalled Due to Labeling Mix-up

    HF Acquisition Co LLC is recalling Glycopyrrolate Injection 0.2mg/mL due to a label mix-up affecting specific lots distributed in Texas, Arizona, and California.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Devices)·Z-1696-2023·2023-06-14

    Abbott Alinity i Anti-TPO Reagent Kit Recalled for Fill Volume Error

    Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.

    Product
    Alinity i Anti-TPO Reagent Kit, List Number 09P3521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V424000·2023-06-13

    Blue Bird Recalls 2022-2024 All American Transit Buses for Brake Warning Defect

    Blue Bird is recalling 2022-2024 All American transit buses because a software error may prevent air pressure gauges and low air warnings from functioning, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V425000·2023-06-13

    Blue Bird Recalls School Buses Due to Air Brake Warning Failure

    Blue Bird is recalling 2021-2024 All American and 2021-2022 Vision school buses because a software error may prevent air pressure warnings from functioning, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V422000·2023-06-13

    Tesla Recalls 2023 Semi Trucks for Door Warning System Defect

    Tesla is recalling 2023 Semi trucks because the door warning system allows drivers to dismiss alerts about unlatched doors, increasing injury risk.

    Product
    TESLA — TESLA SEMI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V421000·2023-06-12

    2022 Nissan Sentra: Driver Cowl Seal Defect May Cause Electrical Failures

    The 2022 Nissan Sentra may have a defective driver's side cowl seal, allowing water intrusion and electrical corrosion. This could cause loss of airbag function, exterior lighting, and braking safety features, increasing crash and fire risk.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2023·2023-06-09

    J.T.M. Provisions Recalls Homestyle Chili Topping for Undeclared Soy Allergen

    J.T.M. Provisions is recalling approximately 200 pounds of ready-to-eat Homestyle Chili Topping because it may contain beef taco filling with undeclared soy.

    Product
    J.T.M. Provisions Company — J.T.M. Provisions Company Recalls Ready-To-Eat Homestyle Chili Topping Product Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·23V418000·2023-06-09

    Ford Recalls 2022-2023 F-150 Lightning Due to Rear Lightbar Defect

    Ford is recalling 2022-2023 F-150 Lightning vehicles because microcracks in the rear lightbar lens can cause reverse lights to fail or flicker.

    Product
    FORD — FORD F-150 LIGHTNING BEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E044000·2023-06-09

    East Penn Recalls Deka 648MF Batteries Due to Electrical Spark Risk

    East Penn is recalling Deka 648MF batteries because an incomplete electrical connection may cause sparks, increasing the risk of injury.

    Product
    ELECTRICAL SYSTEM:12V/24V/48V BATTERY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23E045000·2023-06-09

    SAF-Holland Recalls Suspension Systems Due to Tire Pressure Loss Risk

    SAF-Holland is recalling CBXA40 and ULX40 suspension systems with Tire Pilot Plus management systems because all eight tires may lose pressure at speeds over 45 mph.

    Product
    TIRES:PRESSURE MONITORING AND REGULATING SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·23V420000·2023-06-09

    Ford vehicles recalled for missing head restraint adjustment instructions

    Ford recalls 2018-2023 Expedition, Navigator, and F-Series vehicles lacking head restraint adjustment instructions. Improper adjustment increases crash injury risk.

    Product
    FORD — FORD, LINCOLN F-350 SD, F-250 SD, F-450 SD, F-550 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V413000·2023-06-08

    Jeep Grand Cherokee Models Recalled for Detaching Rear Coil Springs

    Chrysler is recalling certain 2022-2023 Jeep Grand Cherokee and 2021-2023 Jeep Grand Cherokee L vehicles. Rear coil springs may detach while driving, creating a crash risk; dealers will repair them free.

    Product
    JEEP — JEEP GRAND CHEROKEE 4XE, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V411000·2023-06-08

    Chrysler Recalls Jeep and Ram Vehicles for Engine Stall Risk

    Chrysler is recalling 2014-2020 Jeep Grand Cherokee and 2014-2019 Ram 1500 vehicles with 3.0L Diesel engines because a sensor defect may cause the engine to stall, increasing crash risk.

    Product
    JEEP — JEEP, RAM GRAND CHEROKEE, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V417000·2023-06-08

    Altec Recalls 2022-2023 TG-124S Trailers Due to Loose Axle U-Bolts

    Altec is recalling 2022-2023 TG-124S trailers because axle U-bolts may loosen and detach, increasing crash risk. Owners should contact Altec for a free inspection and tightening.

    Product
    ALTEC — ALTEC TG-124S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V414000·2023-06-08

    BMW Recalls 2023 740i, 760i, and i7 for Seat Welding Defect

    BMW is recalling 2023 740i, 760i, and i7 vehicles because front seat length adjustment systems may not be welded properly, increasing injury risk in a crash.

    Product
    BMW — BMW 760I, 740I, I7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23215·2023-06-08

    Ashley Furniture Party Time Recliners Recalled for Fire Hazard

    Ashley Furniture is recalling about 253,000 Party Time power loveseats, sofas, and recliners because the LED cupholder can overheat and cause fire. Consumers should unplug the units and contact the company for a free repair.

    Product
    Party Time Collection Loveseats, Sofas and Recliners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23216·2023-06-08

    Giro Merit Bicycle Helmets Recalled for Head Injury Risk

    Bell Sports is recalling about 15,000 Giro Merit bicycle helmets because they do not meet federal safety standards and can fail to protect in a crash, risking head injury. Consumers should stop using them and contact Giro for a free replacement or refund.

    Product
    Giro Merit Bicycle Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23218·2023-06-08

    Allied Air Enterprises recalls Armstrong and Air Ease gas furnaces for carbon monoxide hazard

    Allied Air Enterprises is recalling about 9,255 Armstrong Air and Air Ease single-stage gas furnaces sold between September 2022 and March 2023 due to improper component assembly that can cause the furnace to produce high levels of carbon monoxide.

    Product
    Armstrong Air and Air Ease single stage gas furnaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23763·2023-06-08

    Narskido Infant Bath Seats Recalled for Drowning Hazard

    TopGlore is recalling about 650 Narskido infant bath seats sold on Amazon because they fail to meet federal safety standards and can tip over, posing a drowning hazard to babies.

    Product
    Narskido Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23765·2023-06-08

    Arctic Cat 8000 Series Snowmobiles Recalled for Fire Hazard

    Textron Specialized Vehicles is recalling about 8,350 Arctic Cat 8000 Series Snowmobiles because the fuel rail dampener snap ring can become loose, leak fuel, and create a fire hazard. Consumers should stop using the snowmobiles immediately and contact the manufacturer for a free inspection and repair.

    Product
    Arctic Cat 8000 Series Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23767·2023-06-08

    Children's Pajamas and Nightdresses Recalled for Flammability Hazard

    Little Cotton Clothes children's pajamas and nightdresses fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 550 units were sold online and in children's clothing stores from September 2022 through January 2023.

    Product
    Little Cotton Clothes Pajamas and Nightdresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23217·2023-06-08

    Haining Degao Benches Recalled Due to Fall Hazard

    TJX is recalling about 10,850 Haining Degao Benches because the legs can break or detach when someone is seated, creating a fall hazard. The company has received 21 reports of legs breaking or detaching at stores, including 17 reports of injuries.

    Product
    Haining Degao Benches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23764·2023-06-08

    Kate and Laurel Mirrors Recalled for Detachment and Laceration Hazard

    Uniek is recalling Kate and Laurel Astora and Valenti mirrors because the mirror glass can detach from the frame and fall, posing a laceration hazard. No injuries have been reported.

    Product
    Kate and Laurel Astora and Valenti Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V415000·2023-06-08

    2023 Hyundai Palisade brake booster defect may cause power brake loss

    Certain 2023 Hyundai Palisade vehicles have a brake booster defect that can cause loss of power brake assist, requiring longer stopping distances and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23766·2023-06-08

    Deux Par Deux Children's Pajamas Recalled for Flammability Standards Violation

    Deux Par Deux children's one-piece and two-piece pajama sets fail to meet federal flammability standards for children's sleepwear, posing a burn hazard. About 90 units sold online from January to February 2023 are affected.

    Product
    Deux Par Deux Children's One-Piece and Two-Piece Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V412000·2023-06-08

    2022 Jeep Grand Cherokee 4XE Recalled for Engine Shutdown Risk

    Chrysler is recalling 2022 Jeep Grand Cherokee 4XE vehicles because a software issue may cause the engine to shut down, increasing crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE 4XE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23768·2023-06-08

    John Deere XUV590 Gator Utility Vehicles Recalled for Fire Hazard

    John Deere is recalling about 1,600 XUV590E, XUV590M, and XUV590M S4 Gator utility vehicles because fuel can leak from under the fuel cap, creating a fire hazard. No injuries have been reported.

    Product
    John Deere™ XUV590E, XUV590M and XUV590M S4 Gator™ utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0963-2023·2023-06-07

    Bean Sprouts from Chang & Son Enterprises Recalled for Listeria Contamination

    Bean sprouts produced by Chang & Son Enterprises, Inc. are recalled due to potential Listeria monocytogenes contamination. Affected products include 10-pound bags and 12-ounce packages with sell-by dates before May 28, 2023.

    Product
    a.) BEAN SPROUTS, 10 LBS, PRODUCT OF USA; CHANG FARM; SO.DEERFIELD, MA; KEEP REFRIGERATED; package in plastic bags b.) Nature's Wonder brand Premium BEAN SPROUTS; ALL NATURAL AND READY TO COOK; NET WT 12 oz (340 g); REFRIGERATE
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0957-2023·2023-06-07

    Living Nutz Nut & Seed Butter Recalled for Potential Salmonella Contamination

    Living Nutz Nut & Seed Butter products have been recalled due to potential Salmonella contamination. The recall affects 68 units distributed across seven states.

    Product
    Living Nutz Nut & Seed Butter Raw Sprouted & Stoneground; 8 oz., 12 oz. or 64 oz.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0964-2023·2023-06-07

    Soybean Sprouts Recalled Due to Potential Listeria Contamination

    Nature's Wonder Premium Soybean Sprouts are recalled due to potential Listeria monocytogenes contamination. Affected products (12 oz bags, UPC 815098001347) were distributed in seven states; discard or return if purchased.

    Product
    Nature's Wonder Premium Soybean Sprouts 12oz bag (UPC: 815098001347)
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0868-2023·2023-06-07

    Pediatric Cough Suppressant G-SUPRESS DX Recalled Due to Product Mix-Up

    G-SUPRESS DX pediatric drops are being recalled due to a product mix-up: an incorrect product was found inside some cartons in Puerto Rico. The recall affects 9,077 bottles (Lot D20911, expires Oct/25).

    Product
    G-SUPRESS DX — G-SUPRESS DX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0970-2023·2023-06-07

    Organic Pineapple Chunks Recalled for Potential Listeria Contamination

    SunOpta Grains and Foods Inc. is recalling Organic Pineapple Chunks due to potential Listeria monocytogenes contamination. Affected lots 8FQ229702000MX and 8FQ229802000MX were distributed in Oregon.

    Product
    Organic Pineapple Chunks, Item 4510-000, packed in 30 lb. poly-lined boxes.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0966-2023·2023-06-07

    Black Fungus Golden Koi Recalled for Possible Salmonella Contamination

    AH USA Group Inc is recalling Black Fungus Golden Koi 2.5 oz packages due to potential salmonella contamination. The product was distributed across 19 states.

    Product
    Black Fungus Golden Koi 2.5 oz packages 100 bags per case UPC: 81005681145 Product of China
    Category
    Food
    Distribution
    19 states
  • SevereNHTSA·23E043000·2023-06-07

    Nissan Recalls Driver-Side Seat Cushion Frames for 2021-2023 Models

    Nissan is recalling driver-side powered seat cushion frames for certain 2021-2023 Rogue, Pathfinder, and INFINITI QX60 vehicles because the seat may not be fully secured, increasing injury risk in a crash.

    Product
    SEATS:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0835-2023·2023-06-07

    FDA Recalls Pilocarpine Ophthalmic Solution Due to Incomplete Stability Studies

    Akorn Inc. recalled all lots of Pilocarpine Hydrochloride Ophthalmic Solution 1% nationwide due to CGMP deviations. The firm went out of business and could not complete required stability studies.

    Product
    Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V410000·2023-06-07

    2023 Kia Sportage Brake Booster Diaphragm Misalignment Recall

    Kia is recalling certain 2023 Sportage vehicles where the brake booster diaphragm may become misaligned, causing a loss of power brake assist and extending vehicle stopping distance.

    Product
    KIA — KIA SPORTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0828-2023·2023-06-07

    Midazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues

    Akorn, Inc. is recalling all lots of Midazolam Injection USP 2mg/2mL nationwide because the manufacturer went out of business and cannot complete required stability studies mandated by Current Good Manufacturing Practice regulations.

    Product
    Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2023·2023-06-07

    Partial Knee Implant Recall Due to Higher-Than-Expected Revision Rates

    Smith & Nephew is recalling 2,146 cementless partial knee implants (ENGAGE system) due to complaint data showing higher-than-expected revision rates compared to similar devices.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0785-2023·2023-06-07

    Artificial Tears Solution Recalled Due to CGMP Deviations and Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.

    Product
    Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0790-2023·2023-06-07

    FDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations

    FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.

    Product
    Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0811-2023·2023-06-07

    Akorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations

    Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.

    Product
    Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0960-2023·2023-06-07

    Fresh Location Chef Salad Recalled Due to Potential Metal Contamination

    The H.T. Hackney Company is recalling Fresh Location Chef Salad with Ranch due to the potential for metal in the product. No illnesses have been reported.

    Product
    Fresh location Chef Salad with Ranch, 8.75oz clear plastic container, UPC 8 55110 00810 7
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0967-2023·2023-06-07

    Turkey and Havarti Sandwich Recalled for Undeclared Sesame Allergen

    Garden Highway Atlanta is recalling approximately 1,147 turkey and havarti sandwiches because sesame was not declared on the product label. The undeclared allergen poses a risk to consumers with sesame allergies.

    Product
    TURKEY AND HAVARTI Sandwich NET WT. 8.55OZ (242g) CONTAINS MILK, SOY, WHEAT MAY CONTAIN EGG Distributed By Rennaissance Food Group, LLC 4322 Moreland Ave Conley, GA UPC 8 26766 15584 2
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0851-2023·2023-06-07

    Tobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Tobramycin Ophthalmic Solution 0.3% because the manufacturer went out of business and could not complete required stability studies, a violation of manufacturing regulations.

    Product
    Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0772-2023·2023-06-07

    Cough medicine recalled due to manufacturing process deviation with non-food lubricant

    Denison Pharmaceuticals is recalling Safe tussin DM DAY TIME Cough Relief due to use of non-food grade lubricant in the manufacturing process. Approximately 86,616 bottles were distributed nationwide.

    Product
    Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0958-2023·2023-06-07

    Fresh location Apple Cranberry Walnut Salad recalled for potential metal contamination

    The H.T. Hackney Company is recalling Fresh location Apple Cranberry Walnut Salad in 7.5 oz containers due to potential metal contamination. Consumers should not consume this product.

    Product
    Fresh location Apple Cranberry Walnut Salad, 7.5oz clear plastic container, UPC 8 55110 00815 2
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0808-2023·2023-06-07

    Guaifenesin Oral Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Guaifenesin Oral Solution nationwide due to CGMP deviations. The manufacturer ceased operations before completing required stability testing to verify the product's safety and efficacy.

    Product
    Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0965-2023·2023-06-07

    Ready-to-eat salmon roll recalled for undeclared sesame allergen

    Origami Catering has recalled Multigrain Spicy Salmon Avocado Roll products due to an undeclared sesame allergen. Sesame seeds are visible on the product but sesame is not listed in the allergen declaration statement.

    Product
    Multigrain Spicy Salmon Avocado Roll, net wt. 7 oz., Ready to Eat, perishable and refrigerated product. UPC 8 51016 00244 7. Manufactured by Origami Catering 828 N Killingsworth St., Portland, OR 97217. The Ingredients statement is read in part: Multigrain Sushi Rice ***, Salmon
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0959-2023·2023-06-07

    Turkey Caesar Salad Recalled Due to Potential Metal Contamination

    The H.T. Hackney Company is recalling Fresh location Turkey Caesar Salad (7.5 oz) due to potential metal contamination. The product was distributed in Illinois, Indiana, Michigan, and Ohio.

    Product
    Fresh location Turkey Caesar Salad, 7.5oz clear plastic container, UPC 8 50036 69402 1
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0962-2023·2023-06-07

    Fresh Caesar Salad Recalled Due to Potential Metal Contamination

    The H.T. Hackney Company is recalling Fresh location Caesar Salad over potential metal contamination. Affected products were distributed in four states with a 'Fresh by' date of 5/19/2023.

    Product
    Fresh location Caesar Salad, 6.00oz clear plastic container, UPC 8 55110 00801 5
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0956-2023·2023-06-07

    Trader Joe's Cold Brew Coffee Recalled for Glass Particles

    Trader Joe's Instant Cold Brew Coffee may contain glass particles. Regal Trading is recalling 14,112 cases distributed in eight states. No illnesses have been reported.

    Product
    Trader Joes Instant Cold Brew Coffee, 3.5 oz.(99g), 24 jars per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0804-2023·2023-06-07

    Fluticasone Propionate Nasal Spray Recalled Due to Manufacturing Quality Concerns

    Akorn, Inc. is recalling all lots of Fluticasone Propionate Nasal Spray, 50mcg due to manufacturing deviations and inability to verify product stability.

    Product
    Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2023·2023-06-07

    Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk

    Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0775-2023·2023-06-07

    Cough Relief Medication Recalled for Non-Food Grade Lubricant Manufacturing Defect

    Denison Pharmaceuticals is recalling Safe tussin PM nighttime cough relief due to use of non-food grade lubricant during manufacturing. Consumers should stop use and consult a pharmacist.

    Product
    Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2023·2023-06-07

    Oxygenator devices recalled due to packaging damage compromising sterile barrier

    Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.

    Product
    BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0849-2023·2023-06-07

    Timolol Maleate Ophthalmic Solution Recalled for Manufacturing and Stability Testing Defects

    Akorn, Inc. has recalled all lots of Timolol Maleate Ophthalmic Solution 0.5% nationwide due to manufacturing quality deviations and inability to complete stability studies.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0816-2023·2023-06-07

    Levetiracetam Oral Solution Recalled Nationwide for Incomplete Stability Testing

    Akorn, Inc. is recalling Levetiracetam Oral Solution nationwide after closing and failing to complete required FDA stability studies. The Class II recall affects all lots distributed in the United States and Puerto Rico.

    Product
    Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2023·2023-06-07

    Cytrellis ellacor Dermal Micro-Coring System Recalled for Potential Scarring

    Cytrellis Biosystems is recalling 89 units of the ellacor System Gen 4 nationwide due to irregular core patterns that may cause prolonged healing, skin texture irregularities, or scarring.

    Product
    Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0814-2023·2023-06-07

    Akorn Lactulose Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.

    Product
    Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0823-2023·2023-06-07

    Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations

    Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.

    Product
    Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2023·2023-06-07

    Smith & Nephew Knee Prosthesis Recalled Due to Higher-Than-Expected Revision Rate

    Smith & Nephew is recalling 1,596 units of its ENGAGE Cementless Partial Knee System due to complaint data indicating higher revision rates than comparable devices. Patients should consult their surgeon.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0827-2023·2023-06-07

    Megestrol Acetate Oral Suspension Recalled for Incomplete Stability Studies

    Akorn recalled all lots of Megestrol Acetate Oral Suspension nationwide due to the firm's inability to complete required stability studies after ceasing operations.

    Product
    Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2023·2023-06-07

    Medical X-Ray Imaging System Recalled for Device Malfunction

    The CS 9600 X-ray imaging system manufactured by Trophy SAS has been recalled worldwide due to failure to function as intended and non-conformance to design specifications. Approximately 895 units are affected.

    Product
    CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿a
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0818-2023·2023-06-07

    Levofloxacin Injection Nationwide Recall Due to Manufacturing Deviations

    Akorn, Inc. has recalled all lots of Levofloxacin Injection nationwide due to manufacturing process violations and inability to complete required stability studies.

    Product
    Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0843-2023·2023-06-07

    Fentanyl Citrate Injection Nationwide Recall Due to Manufacturing Compliance Deviations

    Akorn, Inc. is recalling all lots of Fentanyl Citrate Injection nationwide due to manufacturing compliance deviations. The company was unable to complete required stability studies after ceasing operations.

    Product
    Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0826-2023·2023-06-07

    Lorazepam Oral Concentrate Recalled Due to Manufacturing Practice Deviations

    Akorn, Inc. is recalling all lots of Lorazepam Oral Concentrate (2 mg/mL) due to Current Good Manufacturing Practice deviations. The manufacturer went out of business and could not complete required stability studies.

    Product
    Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0807-2023·2023-06-07

    Akorn Guaiatussin AC Sugar-Free Cough Suppressant Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.

    Product
    Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2023·2023-06-07

    Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number

    Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.

    Product
    TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0820-2023·2023-06-07

    Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations

    Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.

    Product
    Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0961-2023·2023-06-07

    Fresh Location Garden Salad Recalled for Potential Metal Contamination

    The H.T. Hackney Company is recalling Fresh Location Garden Salad with Ranch due to potential metal fragments in the product, which may pose a choking and injury risk.

    Product
    Fresh location Garden Salad with Ranch, 7.25oz clear plastic container, UPC 8 55110 00811 4
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0774-2023·2023-06-07

    Pin-Away Pyrantel Pamoate Recalled for Non-Food-Grade Lubricant Use in Manufacturing

    Denison Pharmaceuticals recalls Pin-Away Pyrantel Pamoate pinworm treatment nationwide due to CGMP deviation: non-food-grade lubricant used in the manufacturing mixing vessel.

    Product
    Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0792-2023·2023-06-07

    Ciclopirox Topical Solution Recalled Due to Manufacturing Practice Violations

    Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.

    Product
    Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0786-2023·2023-06-07

    FDA Recalls All Lots Akorn Artificial Tears Ointment Nationwide

    Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.

    Product
    Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0860-2023·2023-06-07

    Prescription eye solution recalled due to discontinued stability studies

    Akorn, Inc. is recalling all lots of Olopatadine HCl ophthalmic solution 0.2% because the company went out of business and can no longer conduct required stability testing.

    Product
    Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0802-2023·2023-06-07

    Ephedrine Sulfate Injection Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0841-2023·2023-06-07

    Rifampin Capsules Recall: Incomplete Stability Studies Due to Manufacturer Closure

    Akorn Inc. is recalling all lots of Rifampin Capsules USP 300 mg distributed nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required testing.

    Product
    Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0863-2023·2023-06-07

    Ropivacaine Hydrochloride Injection recalled; manufacturer unable to complete stability studies

    Akorn, Inc. recalls all lots of Ropivacaine Hydrochloride Injection nationwide because the manufacturer went out of business and cannot complete required stability studies.

    Product
    Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0825-2023·2023-06-07

    Lorazepam Injection Recalled Due to Manufacturing Control Deviations

    Akorn, Inc. is recalling all lots of Lorazepam Injection, USP 2 mg/mL due to CGMP deviations. The firm ceased operations and could not continue required stability studies.

    Product
    Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0830-2023·2023-06-07

    Naloxone Injection Recall Due to Manufacturing Process Deviations

    Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required stability studies.

    Product
    Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0812-2023·2023-06-07

    FDA Recalls IC-Green Injectable Drug: Manufacturing Deviations Prevent Stability Verification

    Akorn, Inc. recalled all lots of IC-Green injectable drug nationwide because the firm went out of business and could not complete stability studies required to verify manufacturing compliance.

    Product
    IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0800-2023·2023-06-07

    Diuril Injectable Drug Recalled Due to Manufacturing Quality Deviations

    Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required stability studies.

    Product
    Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0836-2023·2023-06-07

    Prednisolone Oral Solution Recalled Due to Manufacturing Standards Deviation

    Akorn, Inc. is recalling all lots of Prednisolone Oral Solution 15 mg/5 mL due to a manufacturing standards deviation. The company discontinued required stability studies after ceasing operations.

    Product
    Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0854-2023·2023-06-07

    Valproic Acid Oral Solution Recalled for Manufacturing Compliance Deviation

    Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL) nationwide. The recall was issued because the firm ceased operations and could not complete required stability studies as mandated by manufacturing regulations.

    Product
    Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0780-2023·2023-06-07

    Acetaminophen & Codeine Oral Solution Recalled Due to Unverified Stability

    Akorn, Inc. is recalling all lots of Acetaminophen & Codeine Oral Solution because stability studies cannot be completed. The firm ceased operations and cannot verify the medication's potency and safety.

    Product
    Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0809-2023·2023-06-07

    HydrALAZINE Injection Recalled Due to Manufacturing Deviations and Unverified Stability

    Akorn, Inc. recalled all lots of HydrALAZINE HCl Injection nationwide because the manufacturer ceased operations and could no longer conduct required stability studies.

    Product
    HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0810-2023·2023-06-07

    Hydrocortisone and Acetic Acid Otic Solution Recalled Due to Manufacturing Deviations

    Akorn, Inc. is recalling all lots of Hydrocortisone and Acetic Acid Otic Solution, USP (10 mL bottles) nationwide due to manufacturing deviations. The company ceased business and could not complete required stability studies to verify product quality.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0815-2023·2023-06-07

    Lactulose Solution Recall Due to Manufacturing Practice Deviations

    Akorn, Inc. has recalled all lots of Lactulose Solution, USP 30 mL Unit Dose Cups nationwide due to the company's inability to continue stability studies after ceasing operations.

    Product
    Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0773-2023·2023-06-07

    Colic Calm Homeopathic Medicine Recalled for Manufacturing Contamination

    Denison Pharmaceuticals is recalling Colic Calm, a homeopathic medicine, due to non-food grade lubricant used in the mixing vessel during manufacturing. Affected lot 8290V was distributed nationwide.

    Product
    Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
    Category
    Drug
    Distribution
    Distributed nationwide

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