The Recall Desk

Archive

March 2020 recalls

515 recalls were announced in March 2020.

What the numbers show

Critical
16
Severe
165
High
214
Moderate
96
Low
24

Of the 515 recalls this month scored against our rubric, 3% are Critical, 32% are Severe.

201–300 of 515

  • HighCPSC·20093·2020-03-18

    Belle Chemical Recalls Sodium and Potassium Hydroxide for Packaging Defects

    Belle Chemical is recalling sodium and potassium hydroxide products because they lack required child-resistant packaging and proper hazard labeling.

    Product
    Sodium Hydroxide, Lye/Caustic Soda and Potassium Hydroxide, Caustic Potash Ash
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20091·2020-03-18

    Novartis Recalls 100 mg Sandimmune and Neoral Blister Packages for Packaging Defect

    Novartis is recalling 100 mg Sandimmune and Neoral blister packages because they fail child-resistant packaging requirements, posing a poisoning risk to children.

    Product
    Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin capsules prescription drug blister packages
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·20725·2020-03-18

    Earth Sonnets Recalls Wintergreen Essential Oil for Packaging Defect

    Earth Sonnets is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Earthsonnets Wintergreen (Gualtheria procumbens) Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0813-2020·2020-03-18

    Tova Industries Recalls Shaver Foods Country Gravy Due to Metal Shavings

    Tova Industries is recalling Shaver Foods brand Country Gravy because of possible metal shavings in an ingredient. The product was distributed to 11 states and the United Arab Emirates.

    Product
    Shaver Foods brand Country Gravy, Item #35379, in 3 lb. metallic pouches, 6 pouches per case.
    Category
    Food
    Distribution
    11 states
  • HighNHTSA·20V157000·2020-03-18

    Daimler Vans Recalls 2019 Sprinter Vehicles Due to Tire Installation Error

    Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because winter tires may be installed incorrectly, reducing traction in wet or snowy conditions.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 1500, SPRINTER 3500, SPRINTER 4500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0828-2020·2020-03-18

    Barts Ice Cream Recalled for Gluten-Free Mislabeling

    Snow's Acquisition, LLC is recalling Barts Ice Cream Co. Chocolate Chip Cookie Dough ice cream because it is mislabeled as gluten-free despite containing wheat flour.

    Product
    Barts Ice Cream Co. brand of Chocolate Chip Cookie Dough ice cream (Vanilla ice cream with chunks of cookie dough and dark chocolate chips) packaged in a white pint paper container (1 pint) with expiration dates from 03/05/21 through 06/04/21 and UPC#: 048896100169.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0825-2020·2020-03-18

    Harris Teeter Banana Pudding Ice Cream Recalled for Undeclared Soy

    Harris Teeter is recalling Premium Selections Banana Pudding Ice Cream because it contains undeclared soy. Consumers should check their freezers for the affected product.

    Product
    PREMIUM SELECTIONS BANANA PUDDING ICE CREAM NATURALLY & ARTIFICIALLY FLAVORED 1.5 QUART (1.42 L) KEEP FROZEN CONTAINS: MILK, WHEAT, COCONUT OIL, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 877-533-2767 UPC 0 72036 43031 1
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0809-2020·2020-03-18

    Riverside Gravy Chicken Recalled for Possible Metal Shavings

    Tova Industries is recalling Riverside brand Gravy Chicken due to possible metal shavings in an ingredient. The product was distributed to 11 states and the United Arab Emirates.

    Product
    Riverside brand Gravy Chicken, Item #35207, in 15 oz. metallic pouches, 8 pouches per case.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0799-2020·2020-03-18

    Sunny Select Au Jus Gravy Mix Recalled for Undeclared Milk

    McCormick is recalling Sunny Select Au Jus Gravy Mix pouches due to undeclared milk. The product was distributed in California and Nevada.

    Product
    Sunny Select Au Jus Gravy Mix 1 OZ pouch (24 pouches per case)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0808-2020·2020-03-18

    Tova Recalls Vegetable Soup Base Due to Possible Metal Shavings

    Tova Industries is recalling 120 bags of National Food Group Vegetable Soup Base due to possible metal shavings in the ingredient.

    Product
    National Food Group brand Soup Base Vegetable, Item #42526, in 40 lb. paper bags.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1428-2020·2020-03-18

    Heartware Recalls HVAD System Battery Charger AC Adapters

    Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.

    Product
    HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination The
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1449-2020·2020-03-18

    Medtronic Simulus 750 Flexible Ring/Band Accessory Kit Recalled for Tissue Contact

    Medtronic CoreValve LLC is recalling six Simulus 750 Flexible Ring/Band Accessory Kits because demonstration units may have contacted non-human tissue.

    Product
    Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0835-2020·2020-03-18

    Stonewall Kitchen Ghost Pepper Salsa Recalled for Undeclared Allergens

    Stonewall Kitchen is recalling Ghost Pepper Salsa because it contains undeclared milk and soy allergens. Consumers should check their pantry for the specific product.

    Product
    Stonewall Kitchen, Ghost Pepper Salsa, Net Weight 454g (16oz), Ingredients: Tomatoes, Jalapeno Peppers, Onion, Tomato Puree, Green Chile Peppers, Distilled Vinegar, Salt, Dehydrated Ghost Pepper, Dehydrated Garlic, Spices, Dehydrated Cilantro. UPC 7 11381 32738 8. BEST BY 23MAY20
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1457-2020·2020-03-18

    EHOB Recalls Econocare Plus Waffle Overlay Due to Blood Contamination

    EHOB, Inc. is recalling specific lots of Econocare Plus Waffle Overlays due to potential contamination with human blood. No instances of contamination have been confirmed in distributed products.

    Product
    Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1454-2020·2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Hypodermic Safety Needles

    Cardinal Health is recalling Monoject Hypodermic Safety Needles because they were shipped as non-sterile despite labeling indicating sterility, posing an infection risk.

    Product
    Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2020·2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Syringes with Safety Needles

    Cardinal Health is recalling Monoject 3mL syringes with safety needles because they were shipped as non-sterile despite labeling. The firm is not aware of any patient harm reports.

    Product
    Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2020·2020-03-18

    BioFire FilmArray Gastrointestinal Panel Recalled for False Negative Results

    BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.

    Product
    FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1455-2020·2020-03-18

    Cardinal Health Recalls Non-Sterile Hypodermic Safety Needles

    Cardinal Health is recalling Monoject Hypodermic Safety Needles that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.

    Product
    Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2020·2020-03-18

    RayStation 8A Software Recalled for Treatment Planning Calculation Errors

    RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.

    Product
    RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1456-2020·2020-03-18

    Cardinal Health Recalls Non-Sterile Monoject Bluntfill Syringes

    Cardinal Health 200, LLC is recalling Monoject Bluntfill syringes that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.

    Product
    Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2020·2020-03-18

    Cordis Recalls POWERFLEX P3 Catheters Due to Potential Seal Voids

    Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.

    Product
    Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1006-2020·2020-03-18

    Redline Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Processing Controls

    Redline Pharmacy Solutions is recalling Acetylcysteine Ophthalmic 10% Solution due to a lack of processing controls. The product was sold to patients in Nebraska.

    Product
    Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1056-2020·2020-03-18

    Lupin Recalls Levonorgestrel and Ethinyl Estradiol Tablets for Content Uniformity

    Lupin Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to failed content uniformity tests.

    Product
    Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1471-2020·2020-03-18

    Verathon Recalls GlideScope Video Laryngoscope Operations and Maintenance Manuals

    Verathon, Inc. is recalling 239 GlideScope Video Laryngoscope Operations & Maintenance Manuals due to a typographical error regarding disinfection instructions.

    Product
    GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-1460-2020·2020-03-18

    Braemar DL950 Holter Monitor Recall Due to Startup Error

    Braemar Manufacturing is recalling DL950 Holter Monitors because a software issue prevents new patient studies from starting.

    Product
    Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1461-2020·2020-03-18

    Response Biomedical Recalls RAMP Cardiac Controls Due to Signal Loss

    Response Biomedical Corp. is recalling RAMP Cardiac Controls because CK-MB levels decreased by up to 57% within 11 months, potentially affecting quality control results.

    Product
    Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2020·2020-03-18

    Binding Site Recalls VaccZyme Human Anti-Haemophilus Influenza Type B Assay Kits

    The Binding Site Group is recalling 462 VaccZyme assay kits due to performance deterioration that may cause falsely elevated antibody results.

    Product
    VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1008-2020·2020-03-18

    Redline Pharmacy Recalls Daptomycin Injectable Due to Processing Control Issues

    Redline Pharmacy Solutions is recalling 16 doses of Daptomycin 500MG injectable sold in Nebraska due to a lack of processing controls.

    Product
    Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1459-2020·2020-03-18

    Braemar DL900 Holter Monitor Recalled for Operational Failure

    Braemar Manufacturing is recalling DL900 Holter Monitors because a software issue prevents new patient studies from starting. Existing recordings can still be downloaded.

    Product
    Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·20094·2020-03-18

    Belle Chemical Recalls Drain Cleaner for Missing Poison Labeling

    Belle Chemical is recalling 100% Sodium Hydroxide Drain Cleaner because the label violates the Federal Hazardous Substance Act by omitting the word 'poison' and mandatory hazard statements.

    Product
    100% Sodium Hydroxide Drain Cleaner
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0998-2020·2020-03-18

    Mayne Pharma Recalls Carbidopa and Levodopa Tablets Due to Foreign Tablet Mix-Up

    Mayne Pharma is recalling specific bottles of Carbidopa and Levodopa Tablets because a foreign tablet was found in a bottle.

    Product
    Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0841-2020·2020-03-18

    Butterfly Shrimp Recalled for Undeclared Sodium Metabisulfite

    Les Chateaux De France is recalling Butterfly Shrimp 16/20 due to undeclared sodium metabisulfite in the coconut ingredient.

    Product
    Butterfly Shrimp 16/20, 50 lb. cases
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0826-2020·2020-03-18

    Siete Grain Free Tortillas Recalled for Sodium Labeling Error

    Garza Food Ventures is recalling Siete Grain Free Burrito Size Tortillas because the sodium content is 340 mg per serving, not the 15 mg declared on the label.

    Product
    Siete Grain Free Burrito Size Tortillas Net Wt 15 oz (423g) 6 count UPC 865336000083 packaged in flexible plastic
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0997-2020·2020-03-18

    Sunstar GUM Toothpaste Recalled for cGMP Deviation in Florida

    Sunstar Guangzhou Ltd. is voluntarily recalling 260,000 tubes of GUM Toothpaste in Florida due to a cGMP deviation. The recall was initiated in February 2020.

    Product
    Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0830-2020·2020-03-18

    Kaiser Mild Banana Pepper Rings Recalled for Possible Foreign Material

    Kaiser Pickles LLC is recalling Mild Banana Pepper Rings due to possible foreign material. The product was distributed to 11 states.

    Product
    Kaiser Mild Banana Pepper Rings 1/4 KK in 1 gallon plastic bottles (4 gallons per case).
    Category
    Food
    Distribution
    11 states
  • LowFDA (Drugs)·D-1055-2020·2020-03-18

    Lupin Recalls Bekyree Tablets Due to Content Uniformity Failures

    Lupin Pharmaceuticals is recalling specific lots of Bekyree oral contraceptives because they failed content and blend uniformity tests.

    Product
    Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1470-2020·2020-03-18

    Integra NeuraGen Nerve Guide Recalled for Quality Control Error

    Integra LifeSciences is recalling 55 units of NeuraGen Nerve Guides because nonconforming product was mistakenly released for commercial use.

    Product
    NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·20090·2020-03-17

    Honda Recalls Portable Generators Due to Fire and Burn Hazards

    American Honda is recalling about 340,000 portable generators because the inverter assembly can short-circuit in salt water, causing smoke or fire.

    Product
    Honda EB2200i, EU2200i, EU2200i Companion and EU2200i Camo Portable Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V148000·2020-03-17

    2020 Thor Sequence motorhomes recalled for transmission shifter cable separation

    Thor Motor Coach is recalling 2020 SEQUENCE motorhomes because the transmission shifter cable may separate from the transmission, potentially causing unintended vehicle movement and increased crash risk.

    Product
    THOR — THOR, THOR MOTOR COACH SEQUENCE, TELLARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V150000·2020-03-17

    Triumph Recalls Trophy Motorcycles Due to Brake Hose Routing Defect

    Triumph is recalling 2013-2017 Trophy SE A1 motorcycles because improper brake hose routing may damage ignition wiring, causing engine stalls or lighting loss.

    Product
    TRIUMPH — TRIUMPH TROPHY, TROPHY SE A1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V149000·2020-03-16

    Audi Recalls Q7 and Q8 Models Due to Steering Shaft Bolt Issue

    Volkswagen Group of America is recalling 2017-2019 Audi Q7 and 2019 Q8 vehicles because a steering shaft bolt may loosen, potentially causing a loss of steering control.

    Product
    AUDI — AUDI Q7, Q8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V147000·2020-03-16

    Eldorado World Trans Recalled for Improperly Secured Seat Belts

    Eldorado National-Kansas is recalling 2017-2019 World Trans vehicles because seat belts may not be properly secured to the side wall, increasing injury risk in a crash.

    Product
    ELDORADO — ELDORADO WORLD TRANS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20T006000·2020-03-13

    Tornel Deportiva Tires Recalled for Tread Separation Risk

    Tornel is recalling specific Deportiva tires where adhesive failure may cause tread separation, increasing the risk of vehicle control loss and crashes.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V145000·2020-03-13

    Nissan Recalls 2020 Infiniti Q60 Vehicles for Rear Seat Belt Defect

    Nissan is recalling 2020 Infiniti Q60 vehicles because the rear seat belt locking mechanism may fail to lock properly, increasing injury risk in crashes.

    Product
    INFINITI — INFINITI Q60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V142000·2020-03-12

    GM Recalls 2020 Silverado and Sierra Trucks for Hood Latch Defect

    General Motors is recalling 2020 Chevrolet Silverado and GMC Sierra trucks because improperly heat-treated hood-latch wires may fracture, allowing the hood to open while driving.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 2500, SILVERADO 3500, SIERRA 2500, SIERRA 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20089·2020-03-12

    Yamaha Recalls Line 6 Relay G10 Wireless Guitar Systems for Fire Hazards

    Yamaha is recalling Line 6 Relay G10 wireless guitar systems because the lithium-ion battery can overheat and the cover can separate, posing fire and injury risks.

    Product
    Line 6 Relay G10 Digital Wireless Guitar Systems and USB Charging Cables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V146000·2020-03-12

    BMW Recalls 2019-2020 Motorcycles Due to Flashing Brake Light Defect

    BMW is recalling specific 2019-2020 motorcycles because the brake light may flash instead of staying steady during emergency braking, which can confuse other drivers.

    Product
    BMW — BMW S1000 R, F 850 GS ADVENTURE, F 900 R, R NINE T SCRAMBLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20088·2020-03-12

    Kichler Recalls 52-inch LED Ceiling Fans Due to Blade Detachment Hazard

    Kichler Lighting is recalling 52-inch LED ceiling fans because the arms holding the blades can detach, posing an injury risk. No injuries have been reported.

    Product
    Kichler 52-inch LED Indoor Ceiling fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0760-2020·2020-03-11

    Blendtopia Superfood Smoothie Kit Recalled for Listeria Contamination

    Blendtopia is recalling Superfood Smoothie Kit Detox flavor pouches due to potential Listeria monocytogenes contamination. Consumers should stop using the product.

    Product
    Blendtopia Superfood Smoothie Kit Detox flavor, 7 oz flexible pouch
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-0759-2020·2020-03-11

    Blendtopia Superfood Smoothie Kit Recalled for Listeria Contamination Risk

    Blendtopia is recalling Superfood Smoothie Kit Glow flavor pouches due to potential Listeria monocytogenes contamination. Consumers should stop using the product.

    Product
    Blendtopia Superfood Smoothie Kit Glow flavor, 7 oz flexible pouch
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Drugs)·D-0994-2020·2020-03-11

    Axia Pharmaceutical Recalls Zinc Chloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Zinc Chloride Injection because the product lacks assurance of sterility.

    Product
    Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0978-2020·2020-03-11

    Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Nicotinamide Adenine Dinucleotide Injection due to a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0979-2020·2020-03-11

    Axia Pharmaceutical Recalls Iohexol Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling Iohexol Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in specific international locations.

    Product
    Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0968-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate/Bupivacaine Injectable Suspension

    Axia Pharmaceutical is recalling Methylprednisolone Acetate/Bupivacaine Injectable Suspension due to a lack of assurance of sterility.

    Product
    Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0623
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0963-2020·2020-03-11

    Axia Pharmaceutical Recalls Lysine Hydrochloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Lysine Hydrochloride Injection because the company cannot ensure the product is sterile.

    Product
    Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0342-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0944-2020·2020-03-11

    Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Betamethasone Acetate/Betamethasone Injectable Suspension due to a lack of assurance of sterility. The product was distributed nationwide and in several territories.

    Product
    BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA Use, Shake Well. 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0621-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0977-2020·2020-03-11

    Axia Pharmaceutical Recalls Nicotinamide Adenine Dinucleotide Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Nicotinamide Adenine Dinucleotide (PF) Injection because the FDA determined there is a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0306-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0976-2020·2020-03-11

    Axia Pharmaceutical Recalls Mitomycin-C Irrigation Solution Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Mitomycin-C Irrigation Solution because the FDA cannot assure the sterility of the product.

    Product
    Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-081
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0973-2020·2020-03-11

    Axia Pharmaceutical Recalls MIC-B12 Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling MIC-B12 Injection because the product lacks assurance of sterility. The recall covers multiple lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refrigerate. Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0230-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0974-2020·2020-03-11

    Axia Pharmaceutical Recalls MIC-PLEX Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling MIC-PLEX Injection in the U.S., Puerto Rico, Barbados, and the Dominican Republic due to a lack of assurance of sterility.

    Product
    MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0233-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0961-2020·2020-03-11

    Axia Pharmaceutical Recalls Levocarnitine Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Levocarnitine Injection because the company cannot guarantee the product's sterility.

    Product
    Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-9260-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0955-2020·2020-03-11

    Axia Pharmaceutical Recalls Glycine Injection Due to Sterility Concerns

    Fusion IV Pharmaceuticals is recalling specific lots of Glycine Injection because the company cannot guarantee the product's sterility.

    Product
    Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0344-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0951-2020·2020-03-11

    Axia Pharmaceutical Recalls Dexamethasone Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling Dexamethasone (LA) Injectable Suspension because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0959-2020·2020-03-11

    Axia Pharmaceutical Recalls Arginine Hydrochloride Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Arginine Hydrochloride Injection because the product lacks assurance of sterility.

    Product
    Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0938-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/30MG/2MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0546-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0995-2020·2020-03-11

    Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns

    Pfizer is recalling 24,714 vials of Elelyso (taliglucerase alfa) for injection due to reports of loose metal ferrule crimps that compromise sterility.

    Product
    ELELYSO — ELELYSO (TALIGLUCERASE ALFA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0972-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the company cannot guarantee the product is sterile.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0636-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0975-2020·2020-03-11

    Axia Pharmaceutical Recalls MIC-PLUS Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling MIC-PLUS Injection, a vitamin complex, due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0231-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0985-2020·2020-03-11

    Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Testosterone Cypionate/Progesterone Injection due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0992-2020·2020-03-11

    Axia Pharmaceutical Recalls Vitamin D3 Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Vitamin D3 Injection due to a lack of assurance of sterility. The affected product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0988-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Acetonide Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide Injectable Suspension because the company cannot ensure the product is sterile.

    Product
    Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2020·2020-03-11

    FDA Recalls LKT200 Perfusion Circuits Due to Leakage Risk

    Organ Recovery Systems is recalling 2,274 LKT200 Perfusion Circuits because leakage at the sample port could cause loss of perfusion solution needed for kidney preservation.

    Product
    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic mach
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1430-2020·2020-03-11

    Remisol Advance software recalled for remote code execution vulnerability

    Normand-Info S.A.S.U. is recalling Remisol Advance software running on unsupported Windows operating systems due to a critical remote code execution vulnerability.

    Product
    Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Drugs)·D-0981-2020·2020-03-11

    Axia Pharmaceutical Recalls Selenium Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Selenium Injection because the product lacks assurance of sterility.

    Product
    Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0991-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0958-2020·2020-03-11

    Axia Pharmaceutical Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Hydroxyprogesterone Caproate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 4 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0532-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0989-2020·2020-03-11

    Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0952-2020·2020-03-11

    Axia Pharmaceutical Recalls Dexpanthenol Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The affected lots were distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0950-2020·2020-03-11

    Axia Pharmaceutical Recalls Deoxycholic Acid Sodium Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Deoxycholic Acid Sodium Injection because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, For SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0462-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0932-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0933-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine/Atropine Injection due to a lack of assurance of sterility.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 40 mcg/25 mg/0.5mg/0.01mg/ml, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0549-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0937-2020·2020-03-11

    Axia Pharmaceutical Recalls Alprostadil Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Alprostadil/Papaverine/Phentolamine Injection due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0545-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0971-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the product lacks assurance of sterility.

    Product
    Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0962-2020·2020-03-11

    Axia Pharmaceutical Recalls Lidocaine HCL Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Lidocaine HCL Injection due to a lack of assurance of sterility. The product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion, protect from light, 5 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1011-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0953-2020·2020-03-11

    Axia Pharmaceutical Recalls Glutathione Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling specific lots of Glutathione Injection because the product lacks assurance of sterility. The recall covers distribution in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1231-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0966-2020·2020-03-11

    Axia Pharmaceutical Recalls Methylcobalamin Injection Due to Sterility Concerns

    Axia Pharmaceutical is recalling Methylcobalamin Injection 10mg/100mg/mL due to a lack of assurance of sterility. The affected product is distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

    Product
    Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM, SC Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0338-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2020·2020-03-11

    Lupin Recalls Desoximetasone Topical Spray Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 876 bottles of Desoximetasone Topical Spray because high out-of-specification impurities were detected.

    Product
    Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
    Category
    Drug
    Distribution
    0 states

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