The Recall Desk

Archive

April 2019 recalls

516 recalls were announced in April 2019.

What the numbers show

Critical
10
Severe
187
High
163
Moderate
133
Low
23

Of the 516 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

1–100 of 516

  • SevereNHTSA·19V338000·2019-04-30

    Spartan Gladiator Aerial Vehicles Recalled for Frame Cracks

    Spartan Motors is recalling 2004-2016 Gladiator aerial vehicles because cracks in the tiller frame may cause the device to fall, risking injury.

    Product
    SPARTAN — SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V337000·2019-04-30

    Smeal Recalls 2017-2019 Aerial Fire Apparatus Due to Missing Welds

    Smeal is recalling 2017-2019 Aerial Fire Apparatus vehicles because missing joint welds in the base rail may cause the aerial device to collapse.

    Product
    SMEAL — SMEAL AERIAL FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19E032000·2019-04-30

    Strategic Sports Recalls Zox Sierra ST-560 Motorcycle Helmets

    Strategic Sports is recalling Zox Sierra ST-560 helmets because they may not adequately protect the wearer in a crash. Owners should return the helmet for a full refund.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V331000·2019-04-30

    Southeast Apparatus Recalls 2017-2018 Fire Trucks Due to Brake Light Defect

    Southeast Apparatus is recalling 39 fire trucks from 2017-2018 because Whelen brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    SOUTHEAST APPARATUS — SOUTHEAST APPARATUS RESCUE TRUCK, TANKER, PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V334000·2019-04-29

    Airstream Recalls 2018-2020 Travel Trailers Due to Spare Tire Carrier Defect

    Airstream is recalling 2018-2020 travel trailers because the spare tire carrier may contact the ground, causing the tire to detach and create a road hazard.

    Product
    AIRSTREAM — AIRSTREAM TOMMY BAHAMA, FLYING CLOUD, INTERNATIONAL, NEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V333000·2019-04-29

    New England Wheels Recalls Modified Ford Transit and Ram Promaster Vehicles

    New England Wheels is recalling 2014-2018 Ford Transit and 2014-2019 Ram Promaster vans modified with Freedman Go-ES Foldaway seats because the seat cushions may not stay locked in place during a crash.

    Product
    FORD — FORD, RAM TRANSIT, PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·19112·2019-04-26

    Kids II Recalls All Rocking Sleepers Due to Infant Death Reports

    Kids II is recalling all Rocking Sleepers because five infant deaths have occurred. Consumers should stop using the product and contact the company for a refund.

    Product
    All models of Kids II Rocking Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V330000·2019-04-26

    Mitsubishi Recalls 2017-2018 Mirage G4 for Air Bag Software Defect

    Mitsubishi is recalling 26,016 2017-2018 Mirage G4 vehicles because a software error may disable air bags. Dealers will reprogram the system free of charge.

    Product
    MITSUBISHI — MITSUBISHI MIRAGE G4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V327000·2019-04-25

    Volvo Recalls 2019 S60 Vehicles for Rear Suspension Lock Nut Issue

    Volvo is recalling 2019 S60 vehicles because rear suspension lock nuts may not be properly tightened, which could cause sudden handling changes and increase crash risk.

    Product
    VOLVO — VOLVO S60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V324000·2019-04-25

    Ram 1500 Recall: Rear Driveshaft Weld Defect May Cause Fracture

    FCA US is recalling 2018-2019 Ram 1500 trucks because an incomplete weld on the rear driveshaft may crack or fracture, creating a road hazard or loss of drive power.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V328000·2019-04-25

    GM Recalls 2017-2019 Chevrolet and GMC Trucks for Fire Risk

    General Motors is recalling specific 2017-2019 Chevrolet Silverado and GMC Sierra trucks because a short circuit in the engine block heater could cause a fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 4500, SILVERADO 2500, SILVERADO 3500, SIERRA 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19111·2019-04-25

    Viessmann Recalls Vitodens Boilers Due to Carbon Monoxide Hazard

    Viessmann is recalling Vitodens 200-W and 222-F boilers because a corroded heat exchanger can leak flue gases, posing a carbon monoxide poisoning hazard.

    Product
    Vitodens boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V326000·2019-04-25

    Jaguar Recalls 2014-2015 F-TYPE Vehicles for Air Bag Sensor Wiring Issue

    Jaguar is recalling 2014-2015 F-TYPE vehicles because a seatbelt sensor wiring error may cause the front passenger air bag to deploy incorrectly, increasing injury risk for children.

    Product
    JAGUAR — JAGUAR F-TYPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19742·2019-04-25

    TriDerma Recalls Pain Relief Cream for Child-Resistant Packaging Failure

    TriDerma is recalling Pain Relief Cream with Lidocaine because the packaging fails to meet child-resistant closure requirements, posing a poisoning risk to young children.

    Product
    Pain Relief Cream with Lidocaine
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1206-2019·2019-04-24

    Herbal Coffee Recalled for Undeclared Erectile Dysfunction Drugs

    The FDA is recalling Kopi Jantan Tradisional Natural Herbs Coffee because it contains undeclared sildenafil and tadalafil, unapproved drugs for erectile dysfunction.

    Product
    Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1288-2019·2019-04-24

    NadaMoo! Strawberry Cheesecake Frozen Dessert Recalled for Undeclared Almonds

    Little Red Rooster Company is recalling NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert because it contains undeclared almonds.

    Product
    NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert 16 ounce/pint packaged in a carton
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Drugs)·D-1199-2019·2019-04-24

    Phenol Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Phenol 10% Injection due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1144-2019·2019-04-24

    Gentamicin Irrigation Syringes Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Gentamicin irrigation syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1126-2019·2019-04-24

    MSM Eye Drops Recalled for Lack of Sterility Assurance

    MSM Nutraceuticals is recalling 15% MSM Eye Drops because the product is not terminally sterilized and was not tested per USP 71.

    Product
    15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2019·2019-04-24

    Polyhexamethylene Biguanide Ophthalmic Drops Recalled for Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling Polyhexamethylene Biguanide 0.02% Ophthalmic Drops due to a lack of sterility assurance.

    Product
    Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1195-2019·2019-04-24

    Estrone Oil Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Estrone 5mg/mL Oil Injection nationwide due to a lack of sterility assurance.

    Product
    Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1157-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcain Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling specific 60 mL syringes containing Heparin, Marcain, Sodium Bicarbonate, and Normal Saline due to a lack of sterility assurance.

    Product
    Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1182-2019·2019-04-24

    FDA Recalls Vitamin D3 Injection Due to Sterility Assurance Concerns

    Anderson Compounding Pharmacy is recalling Vitamin D3 200,000 IU/mL Injection vials nationwide due to a lack of sterility assurance.

    Product
    Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1129-2019·2019-04-24

    MSM Nutraceuticals Recalls Dr. Berne's MSM Drops Due to Sterility Concerns

    MSM Nutraceuticals is recalling 500 bottles of Dr. Berne's MSM Drops because the product lacks assurance of sterility and was not tested per USP 71.

    Product
    Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1204-2019·2019-04-24

    FDA Recalls Prostaglandin Tri-Mix Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 30:30:1 Injection vials nationwide due to a lack of sterility assurance.

    Product
    Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2019·2019-04-24

    Phenylephrine Injection Recalled Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Phenylephrine 1 mg/mL Injection vials nationwide because the product lacks sterility assurance.

    Product
    Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1139-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Amphotericin B Eye Drops for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Amphotericin B 0.15% Eye Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·048-2019·2019-04-24

    Grant Park Packing Recalls Raw Ground Beef Due to E. coli O103

    Grant Park Packing is recalling approximately 53,200 pounds of raw ground beef that may be contaminated with E. coli O103. The products were shipped to Minnesota and Kentucky.

    Product
    Grant Park Packing — Grant Park Packing Recalls Raw Ground Beef Products Due to Possible E. coli O103 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1151-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 99 vials of HCG 20 Day Extra Strength nationwide due to a lack of sterility assurance.

    Product
    HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1174-2019·2019-04-24

    FDA Recalls Prostaglandin Tri-Mix Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 50:30:1 vials nationwide due to a lack of sterility assurance.

    Product
    Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1200-2019·2019-04-24

    Prostaglandin Tri-Mix Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix Injection due to lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1187-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Neomycin and Polymixin B Bladder Irrigation Solution

    Anderson Compounding Pharmacy is recalling Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution due to a lack of sterility assurance.

    Product
    Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1190-2019·2019-04-24

    Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Sodium Bicarbonate 8.4% Injection vials due to a lack of sterility assurance.

    Product
    Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1178-2019·2019-04-24

    Serum Tears 30% Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Serum Tears 30% Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1191-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcaine Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Heparin and Marcaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1186-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Injection for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix 60:30:1 Injection due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1185-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Interferon Eye Drops for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Interferon 1 Million IU/mL Eye Drops due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1173-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling 58 vials of Prostaglandin Tri-Mix 20:30:1 due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1128-2019·2019-04-24

    MSM Red Eye Eye Drops Recalled for Sterility Assurance Issues

    MSM Nutraceuticals is recalling Red Eye Eye Drops because the product lacks assurance of sterility and was not tested per USP 71.

    Product
    Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2019·2019-04-24

    FDA Recalls Volumex Injection Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results indicate sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1155-2019·2019-04-24

    FDA Recalls HCG 40 Day Injection Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 40 Day Injection Extra Strength vials nationwide due to a lack of sterility assurance.

    Product
    HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1183-2019·2019-04-24

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylcobalamin 3000 mcg/mL Injection Solution due to a lack of sterility assurance.

    Product
    Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1179-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Energy Risk

    Gyrus ACMI, Inc. is recalling Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1171-2019·2019-04-24

    Prostaglandin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin Quad-Mix Injection vials due to a lack of sterility assurance.

    Product
    Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Sermorelin Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 22 vials of Sermorelin 0.3 mg/0.5 mL nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1138-2019·2019-04-24

    FDA Recalls Atropine Eye Drops Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Atropine 0.01% Eye Drops because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1177-2019·2019-04-24

    Serum Tears 20% Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Serum Tears 20% Drops due to a lack of sterility assurance. All lots of the 1 mL droptainers are affected.

    Product
    Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1161-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Methionine Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 276 vials of a methionine and choline injection nationwide due to a lack of sterility assurance.

    Product
    Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1170-2019·2019-04-24

    Prostaglandin Vials Recalled Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Prostaglandin 60 mcg/mL vials nationwide due to a lack of sterility assurance.

    Product
    Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2019·2019-04-24

    Heparin and Lidocaine Syringes Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Heparin and Lidocaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1149-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG 23 Day Vials for Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 23 Day vials nationwide due to a lack of sterility assurance. Consumers should stop using the product.

    Product
    HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1147-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 11,000 Units vials nationwide because the product lacks sterility assurance.

    Product
    HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1141-2019·2019-04-24

    Dexamethasone Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Dexamethasone 24 mg/mL Injection vials due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1148-2019·2019-04-24

    FDA Recalls HCG 20 Day Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 20 Day Injection vials nationwide due to a lack of sterility assurance.

    Product
    HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Bupivacaine Syringes

    Anderson Compounding Pharmacy is recalling Heparin 10,000 U/Bupivacaine 0.5% syringes due to a lack of sterility assurance.

    Product
    Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2019·2019-04-24

    Gentamicin Sterile Water Recall Due to Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Gentamicin 240 mg/500 mL Sterile Water for Irrigation due to a lack of sterility assurance.

    Product
    Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1164-2019·2019-04-24

    Morphine Sulfate Inhalation Vials Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Morphine Sulfate 5 mg/3mL inhalation vials due to a lack of sterility assurance. The recall covers 60 vials distributed nationwide.

    Product
    Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1179-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Streptomycin and Dexamethasone Otic Injection

    Anderson Compounding Pharmacy is recalling Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection due to a lack of sterility assurance.

    Product
    Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcain Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling 12 syringes of a Heparin, Marcain, and Sodium Bicarbonate mixture due to a lack of sterility assurance.

    Product
    Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1188-2019·2019-04-24

    Lidocaine Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Lidocaine 1%/Dextrose 12.5% Injection vials due to a lack of sterility assurance.

    Product
    Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1160-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Lidocaine Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Heparin and Lidocaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1201-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Tri-Mix Injection vials because they lack sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1180-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Bacitracin Irrigation Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Bacitracin 3000U/30 mL Irrigation syringes nationwide due to a lack of sterility assurance.

    Product
    Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 57 vials of HCG 30 Day due to a lack of sterility assurance. The products were distributed nationwide.

    Product
    HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1176-2019·2019-04-24

    Sermorelin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Sermorelin 0.4 mg/0.5 mL vials nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1162-2019·2019-04-24

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL Injection vials due to a lack of sterility assurance.

    Product
    Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1152-2019·2019-04-24

    FDA Recalls HCG 20,000 Units Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 20,000 units/vial products nationwide due to a lack of sterility assurance.

    Product
    HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1197-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Papaverine and Phentolamine Vials

    Anderson Compounding Pharmacy is recalling Papaverine 30 mg/Phentolamine 0.5 mg/mL vials due to a lack of sterility assurance.

    Product
    Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1142-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls DMSO and Heparin Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling DMSO 50% and Heparin syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1145-2019·2019-04-24

    Gentamicin Irrigation Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Gentamicin 250 mg/1000 mL Irrigation due to a lack of sterility assurance. The recall covers 4 bottles distributed nationwide.

    Product
    Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1168-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling 23 vials of Prostaglandin 20 mcg/mL due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1172-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Prostaglandin Quad Vials Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Prostaglandin Quad with Atropine vials because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 1,000 U/mL Injection vials nationwide due to a lack of sterility assurance.

    Product
    HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1194-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Heparin and Marcaine Syringes for Sterility Concerns

    Anderson Compounding Pharmacy is recalling Heparin and Marcaine syringes due to a lack of sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1082-2019·2019-04-24

    Brainlab Spine & Trauma 3D Navigation Software Recall for Display Error

    Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.

    Product
    Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1094-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap used during assembly.

    Product
    icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1137-2019·2019-04-24

    Acetylcysteine Eye Drops Recalled for Lack of Sterility Assurance

    Anderson Compounding Pharmacy is recalling Acetylcysteine 10% Ophthalmic Eye Drops due to a lack of sterility assurance.

    Product
    Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1196-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 11,000 mcg Injection vials nationwide due to a lack of sterility assurance.

    Product
    HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1192-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Gentamicin Sterile Water for Irrigation

    Anderson Compounding Pharmacy is recalling Gentamicin 160 mg/1000 mL Sterile Water for Irrigation due to a lack of sterility assurance.

    Product
    Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V321000·2019-04-24

    LDJ Recalls 2017-2018 R250 Trailers Due to Axle Installation Defects

    LDJ is recalling 2017-2018 R250 Container trailers because axles may be installed backwards or unwelded, potentially causing brake failure and increasing crash risk.

    Product
    LDJ — LDJ R250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1189-2019·2019-04-24

    FDA Recalls EDTA 1% Sterile Injection Due to Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling EDTA 1% Sterile Injection (Preservative Free) nationwide due to a lack of sterility assurance.

    Product
    EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1154-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG Injection Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling HCG 4,100 Units/vial Injection nationwide due to a lack of sterility assurance.

    Product
    HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1184-2019·2019-04-24

    Serum Tears 50% Ophthalmic Drops Recalled for Sterility Assurance Issues

    Anderson Compounding Pharmacy is recalling Serum Tears 50% Ophthalmic Drops due to a lack of sterility assurance. All lots are affected nationwide.

    Product
    Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1185-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Turbinate Blades Due to RF Activation Risk

    Gyrus ACMI is recalling 21 Diego Elite Turbinate Blades because they may allow unintended RF energy activation when used with specific consoles.

    Product
    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1127-2019·2019-04-24

    MSM Nutraceuticals Recalls Dry Eye Eye Drops for Sterility Concerns

    MSM Nutraceuticals is recalling Dry Eye Eye Drops because the product was not terminally sterilized and was not tested per USP 71.

    Product
    Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1153-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls HCG 23 Day Injection Vials

    Anderson Compounding Pharmacy is recalling HCG 23 Day Injection Extra Strength vials nationwide due to a lack of sterility assurance.

    Product
    HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V322000·2019-04-24

    Porsche Recalls Panamera Models Due to Electrical Fire Risk

    Porsche is recalling 2010-2016 Panamera vehicles because water in the A/C blower control unit can cause an electrical short and fire.

    Product
    PORSCHE — PORSCHE PANAMERA, PANAMERA S E-HYBRID, PANAMERA S, PANAMERA 4S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1165-2019·2019-04-24

    Anderson Compounding Pharmacy Recalls Penicillin G Syringes Due to Sterility Concerns

    Anderson Compounding Pharmacy is recalling Penicillin G 100,000/mL 10 mL Syringes because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

    Product
    Penicillin G 100,000/mL 10 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1186-2019·2019-04-24

    Gyrus ACMI Recalls Diego Elite Blades Due to RF Energy Activation Risk

    Gyrus ACMI, Inc. is recalling Diego Elite Blades Monopolar because they may allow unintended RF energy activation when used with Olympus consoles.

    Product
    Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
    Category
    Medical Device
    Distribution
    Distributed nationwide

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