The Recall Desk

Archive

October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical
63
Severe
381
High
255
Moderate
88
Low
20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 47% are Severe.

401–500 of 807

  • SevereFDA (Drugs)·D-0008-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Cromolyn Sodium Inhalation Solution

    Colonia Care Pharmacy is recalling C-Cromolyn Sodium 20 mg/2 mL inhalation solution due to a lack of assurance of sterility.

    Product
    C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2741-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 26 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2679-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 219 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2620-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 524 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0, .070", REF SA6JL30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2698-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 30 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2746-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.0, .070", REF SA6SL30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0089-2020·2019-10-09

    FDA Recalls Phenylephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling Phenylephrine HCl IV infusion bags because the company cannot ensure the product is sterile.

    Product
    PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2582-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2622-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 2,607 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2701-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 9 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2681-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 23 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2570-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 655 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0070-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine and Hyaluronidase Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl and Hyaluronidase syringes due to a lack of assurance of sterility. The recall covers 2,615 syringes distributed nationwide.

    Product
    Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2708-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75 SH, .070", REF SA6SAL75SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2569-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 1,491 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2591-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 12 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2639-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 573 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2562-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 1,226 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0041-2020·2019-10-09

    KRS Global Biotechnology Recalls Ascorbic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 602 vials of Ascorbic Acid (Tapioca Source) 25 g/50 mL due to a lack of assurance of sterility.

    Product
    Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection

    KRS Global Biotechnology is recalling 3,150 vials of Phenylephrine HCl and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.

    Product
    PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2651-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 159 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0, .070", REF SA6RBU40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2643-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    Medtronic Vascular is recalling 1,495 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5, .070", REF SA6JR35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0018-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Methylcobalamin Injections Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 191 syringes of C-Methylcobalamin 25mg/mL injection because the product's sterility cannot be guaranteed.

    Product
    C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0051-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,882 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0079-2020·2019-10-09

    KRS Global Biotechnology Recalls IV Nicotinamide Adenine Dinucleotide Vials

    KRS Global Biotechnology is recalling 4,390 vials of IV Nicotinamide Adenine Dinucleotide due to a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0065-2020·2019-10-09

    KRS Global Biotechnology Recalls Ketamine Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 11,733 syringes of Ketamine in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0011-2020·2019-10-09

    Colonia Care Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Gentamicin injection because the sterility of the product cannot be guaranteed.

    Product
    C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2678-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 30 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F AL4.0, .070", REF SA6AL40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2684-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 163 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0006-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution

    Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.02% because the product's sterility cannot be guaranteed.

    Product
    C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2730-2019·2019-10-09

    Medtronic Recalls 18 Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 18 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0087-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 228 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.

    Product
    PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2020·2019-10-09

    FDA Recalls Hyaluronidase Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling 928 vials of Hyaluronidase Ophthalmic Injection because the product lacks assurance of sterility.

    Product
    Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0073-2020·2019-10-09

    KRS Global Biotechnology Recalls Methylcobalamin Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,189 vials of Methylcobalamin injection nationwide due to a lack of assurance of sterility.

    Product
    Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2617-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 32,484 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0036-2020·2019-10-09

    Quality Electrodynamics Recalls MRI Knee Coils Due to Ferrous Material Risk

    Quality Electrodynamics LLC is recalling 36 Siemens MRI knee coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2604-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling specific 6F Sherpa NX Active Guiding Catheters because a defect may cause material loss, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0030-2020·2019-10-09

    Colonia Care Pharmacy Recalls Sterility-Compromised C-Papav/Phentol/PGE1 Vials

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0076-2020·2019-10-09

    KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling Moxifloxacin 0.1% ophthalmic injection syringes due to a lack of assurance of sterility. The recall covers 9,920 syringes distributed nationwide.

    Product
    Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2020·2019-10-09

    KRS Global Biotechnology Recalls Alpha Lipoic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 77 vials of Alpha Lipoic Acid for IV use nationwide due to a lack of assurance of sterility.

    Product
    Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2655-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 117 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2581-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 215 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2629-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 303 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0071-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine/Bupivacaine/Hyaluronidase ophthalmic injections due to a lack of assurance of sterility.

    Product
    LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2726-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 14 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5, .070", REF SA6ECR35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2712-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 113 units of Sherpa NX Active Guiding Catheters due to a potential loss of material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F RRAD, .070", REF SA6RRAD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0123-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets

    Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide tablets due to the presence of an impurity above acceptable levels.

    Product
    Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2665-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 56 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0 SH, .070", REF SA6JL50SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0045-2020·2019-10-09

    KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling L-Carnitine vials because the company cannot ensure the product is sterile. The recall covers 6,447 vials distributed nationwide.

    Product
    L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 649 droptainers of a sterile ophthalmic solution because the company cannot ensure the product's sterility.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2608-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 8 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0024-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns

    Colonia Care Pharmacy is recalling 7 vials of C-Papav/Phentol/PGE1 due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2744-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling six units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAR2.0 .070", REF SA6SAR20. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0031-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Phenol Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5% vials because the sterility of the product cannot be guaranteed.

    Product
    C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2633-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 496 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2735-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 20 units of Sherpa NX Active Guiding Catheters due to potential loss of segment material exposing stainless-steel wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2654-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 120 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0, .070", REF SA6CHAMP10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2658-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 567 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0, .070", REF SA6JL50. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2605-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters due to potential loss of segment material exposing stainless-steel wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2657-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 746 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1, .070", REF SA6MP1. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2739-2019·2019-10-09

    Medtronic Vascular Recalls Six Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0017-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-MB12 NAC Injection Syringes for Sterility Concerns

    Colonia Care Pharmacy is recalling 15 syringes of C-MB12 NAC injection solution because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0064-2020·2019-10-09

    FDA Recalls Ketamine Syringes Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 1,044 syringes of Ketamine in 0.9% Sodium Chloride because the product lacks assurance of sterility.

    Product
    Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2714-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 11 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2634-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 2,818 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL3.5, .070", REF SA6SL35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2595-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 2 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2664-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 406 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0 SH, .070", REF SA6JL40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0032-2020·2019-10-09

    Quality Electrodynamics Recalls 3 Siemens Knee Coils Due to Ferrous Material

    Quality Electrodynamics LLC is recalling three Siemens 1.5T Knee Coils because unintended ferrous material may be present in the pushbutton assembly.

    Product
    TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0021-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific lots of C-Papav/Phentol/PGE1 vials because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0095-2020·2019-10-09

    FDA Recalls Sermorelin Vials Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling 647 vials of Sermorelin and related peptides because the company cannot ensure the products are sterile.

    Product
    Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2020·2019-10-09

    KRS Global Biotechnology Recalls Quadmix #13A Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 91 vials of Quadmix #13A because the company cannot ensure the product is sterile.

    Product
    Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2020·2019-10-09

    KRS Global Biotechnology Recalls Lyophilized Injection Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 497 vials of a lyophilized injection product because the company cannot ensure the product is sterile.

    Product
    Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2673-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 97 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1 SH, .070", REF SA6MB1SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2749-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 12 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.0, .070", REF SA6CHAMP30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0016-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-MB12/HB12 Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling six syringes of C-MB12/HB12 5MG/5MG/ML Injection Solution because the product's sterility cannot be guaranteed. The affected lot was distributed via patient-specific prescriptions in New Jersey.

    Product
    C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0080-2020·2019-10-09

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 528 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2721-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 51 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0 SH, .070", REF SA6JR30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2616-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 8,966 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.0, .070", REF SA6JL40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0090-2020·2019-10-09

    KRS Global Biotechnology Recalls Polidocanol Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 317 vials of Polidocanol 5% for IV use nationwide due to a lack of assurance of sterility.

    Product
    Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2653-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 80 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2, .070", REF SA6MB2. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2647-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 121 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MP1 SH, .070", REF SA6MP1SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2704-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recall for Material Loss

    Medtronic Vascular is recalling 11 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JCL3.5, .070", REF SA6JCL35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2680-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 82 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII, .070", REF SA6HSII. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0105-2020·2019-10-09

    FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 3,820 syringes of Succinylcholine Chloride because the company cannot guarantee the product is sterile.

    Product
    SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2020·2019-10-09

    FDA Recalls Fentanyl IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 934 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.

    Product
    fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0094-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Injections Due to Sterility Concerns

    KRS Global Biotechnology is recalling Sermorelin Acetate injections because the company cannot ensure the product is sterile. The recall covers 218 cartridges distributed nationwide.

    Product
    Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2592-2019·2019-10-09

    Medtronic Recalls 10 Units of Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 10 units of Sherpa NX Active Guiding Catheters due to a potential loss of segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2692-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Structural Defect

    Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR4.0 SH, .070", REF SA6ECR40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0113-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.

    Product
    Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2598-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 8 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0022-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2588-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 12 units of the SHERPA NX ACTIVE GUIDING CATHETER because a subset may experience extensive loss of primary segment material, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0088-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 708 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.

    Product
    PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0027-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2612-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    Medtronic Vascular is recalling specific Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, 110CM, .070" REF SA6JR40SHA. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0019-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns

    Colonia Care Pharmacy is recalling 6 vials of C-Papav/Phentol/PGE1 due to a lack of assurance of sterility. The affected product was distributed via patient-specific prescriptions in New Jersey.

    Product
    C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2576-2019·2019-10-09

    Medtronic Recalls 18 Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 18 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0086-2020·2019-10-09

    KRS Global Biotechnology Recalls Phenylephrine Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 15,260 syringes of Phenylephrine HCl injection nationwide due to a lack of assurance of sterility.

    Product
    PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0121-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
    Category
    Drug
    Distribution
    Distributed nationwide

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