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.

501–600 of 807

  • SevereFDA (Devices)·Z-2631-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 531 units of Sherpa NX Active Guiding Catheters due to potential loss of primary segment material exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0028-2020·2019-10-09

    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 product's sterility cannot be guaranteed.

    Product
    C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/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-2610-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 246 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 100CM 3DRC, REF SA63DRCSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2566-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 4 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0093-2020·2019-10-09

    KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns

    KRS Global Biotechnology is recalling 258 vials of Sermorelin Acetate and GHRP-2 because the product lacks assurance of sterility.

    Product
    Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2737-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 29 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 CHAMP1.5 SH, .070", REF SA6CHAMP15SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0114-2020·2019-10-09

    KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.

    Product
    Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2020·2019-10-09

    KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,290 syringes of Moxifloxacin 0.1% ophthalmic injection nationwide due to a lack of assurance of sterility.

    Product
    Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2748-2019·2019-10-09

    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 MAC3.75 SH, .070", REF SA6MAC375SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2733-2019·2019-10-09

    Medtronic 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 primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC5.0, .070", REF SA6MAC50. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2702-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss

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

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII, .070", REF SA6HSIII. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2700-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling six 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 AL2.5, .070:, REF SA6AL25. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2695-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 10 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 CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2648-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 136 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 JL6.0, .070", REF SA6JL60. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2703-2019·2019-10-09

    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 SAR1.0, .070", REF SA6SAR10. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2611-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3 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 110CM AL20, REF SA6AL20A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2663-2019·2019-10-09

    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 MB2 SH, .070", REF SA6MB2SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2614-2019·2019-10-09

    Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss

    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 SR3.5 SH, .070" REF SA6SR35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2586-2019·2019-10-09

    Medtronic Recalls Two Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling two units of the Sherpa NX Active Guiding Catheter 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 SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0117-2020·2019-10-09

    KRS Global Biotechnology Recalls L-Asparaginase Lyophilized Due to Sterility Concerns

    KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.

    Product
    L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2590-2019·2019-10-09

    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, JL4.0, 90CM, 070", REF SA6JL40D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0055-2020·2019-10-09

    KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,625 syringes of Glycopyrrolate (PF) 1 mg/5 mL due to a lack of assurance of sterility.

    Product
    GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 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. NDC03321678317
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2723-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling six 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 SAL2.0 SH, .070", REF SA6SAL20SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2742-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 33 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0040-2020·2019-10-09

    KRS Global Biotechnology Recalls Ascorbic Acid Vials Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,219 vials of Ascorbic Acid (Tapioca Source) 25 g/50 mL due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2743-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 5 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 CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2597-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling specific 6F Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0103-2020·2019-10-09

    KRS Global Biotechnology Recalls Succinylcholine Chloride Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling 7,905 syringes of Succinylcholine Chloride (PF) due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.

    Product
    SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2732-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling six units of the Sherpa NX Active Guiding Catheter 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 LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0107-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.

    Product
    Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2693-2019·2019-10-09

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

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

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F HSIII SH, .070", REF SA6HSIIISH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2738-2019·2019-10-09

    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 SCR3.5 SH, .070", REF SA6SCR35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2720-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 5 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 SAL3.0, .070", REF SA6SAL30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0044-2020·2019-10-09

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

    KRS Global Biotechnology is recalling L-Carnitine vials nationwide because the company cannot ensure the product is sterile.

    Product
    L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0109-2020·2019-10-09

    KRS Global Biotechnology Recalls Ophthalmic Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.

    Product
    Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 339 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 JR5.0, .070", REF SA6JR50. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0025-2020·2019-10-09

    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 30MG/0.5MG/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 (Drugs)·D-0083-2020·2019-10-09

    KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee the product is sterile.

    Product
    OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2719-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 45 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 SCR4.0, .070", REF SA6SCR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2640-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 143 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 EBU5.0, .070", REF SA6EBU50. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2579-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 20 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2649-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 87 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 3DRIGHT SH .070", REF SA63DRIGHTSH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0082-2020·2019-10-09

    KRS Global Biotechnology Recalls Norepinephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.

    Product
    Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 6F Sherpa NX Active Guiding Catheters because a potential loss of primary segment material may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.5, .070", REF SA6JL35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0034-2020·2019-10-09

    Colonia Care Pharmacy Recalls Verapamil Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling Verapamil 2.5mg/mL injection vials because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-VERAPAMIL 2.5MG/ML INJ SOLN, 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-2677-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 45 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 SCR3.5, .070", REF SA6SCR35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2609-2019·2019-10-09

    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 loss of primary segment material, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2672-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 33 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 SH, .070", REF SA6AL30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2593-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 5 units of SHERPA NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2710-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 26 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2567-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling specific 6F 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, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2697-2019·2019-10-09

    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 a potential loss of primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0052-2020·2019-10-09

    KRS Global Fluorescein Vials Recalled for Sterility Assurance Issues

    KRS Global Biotechnology is recalling Fluorescein vials because the company cannot guarantee the product is sterile.

    Product
    Fluorescein (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 3321676632
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2706-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 3 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 RCBII, .070", REF SA6RCBII. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2724-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 34 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 ERAD RIGHT, .070", REF SA6ERADR. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2623-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 1,364 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 AL2.0, .070", REF SA6AL20. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2661-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 49 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 JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2690-2019·2019-10-09

    SHERPA NX Active Guiding Catheter recall due to exposed stainless-steel braid wires

    A recall of Medtronic Vascular SHERPA NX active guiding catheters was issued because some units may expose underlying stainless-steel braid wires, posing a potential safety risk.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0118-2020·2019-10-09

    KRS Global Biotechnology Recalls Isoproterenol HCL IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling Isoproterenol HCL IV bags because the company cannot ensure the product is sterile.

    Product
    Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2578-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 17 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, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2688-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 247 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 LARA, .070", REF SA6LARA. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2573-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 29 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, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2716-2019·2019-10-09

    Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 10 units of SHERPA NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F FR4.0, .070", REF SA6FR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2607-2019·2019-10-09

    Medtronic Recalls 6F Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 4 units of 6F 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, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2718-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 56 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, SHORT TIP, .070", REF SA6ERADLST. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0067-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine and Epinephrine Syringes for Sterility Concerns

    KRS Global Biotechnology is recalling 4,105 syringes of Lidocaine and Epinephrine due to a lack of assurance of sterility.

    Product
    LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2731-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

    Medtronic Vascular is recalling 9 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 ECR4.0, .070", REF SA6ECR40. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0009-2020·2019-10-09

    Colonia Care Pharmacy Recalls Dexamethasone Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling 37 vials of C-Dexamethasone 24mg/mL injection solution because the sterility of the product cannot be guaranteed.

    Product
    C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2642-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 213 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 JL3.5 SH, .070", REF SA6JL35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2574-2019·2019-10-09

    Medtronic Recalls Six Sherpa NX Active Guiding Catheters for Structural Defect

    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, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0043-2020·2019-10-09

    FDA Recalls Bimix #3 Vials Due to Lack of Sterility Assurance

    KRS Global Biotechnology is recalling Bimix #3 vials because the company cannot ensure the product is sterile.

    Product
    Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2584-2019·2019-10-09

    Medtronic Vascular Recalls Sherpa NX Active Guiding Catheters

    Medtronic Vascular is recalling 53 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, 90CM, 070", REF SA6IMAD . for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0054-2020·2019-10-09

    KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.

    Product
    GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2020·2019-10-09

    KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns

    KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2656-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 69 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 EBU4.5 SH, .070", REF SA6EBU45SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2613-2019·2019-10-09

    Medtronic 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 primary segment material that could expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SR3.5, .070" REF SA6SR35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2637-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters for Material Loss

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

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0 SH, .070", REF SA6SCR40SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0010-2020·2019-10-09

    Colonia Care Pharmacy Recalls C-EDETATE DISODIUM 1.5% Ophthalmic Solution

    Colonia Care Pharmacy is recalling specific lots of C-EDETATE DISODIUM 1.5% Ophthalmic Solution because the sterility of the product cannot be guaranteed.

    Product
    C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0068-2020·2019-10-09

    KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling Lidocaine HCl 1% syringes because the company cannot guarantee the product is sterile.

    Product
    LIDOcaine HCl 1% (PF) 50 mg/5 mL (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 3321678424
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2563-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 658 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, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2669-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 76 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 MP ST, .070", REF SA6MPST. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0099-2020·2019-10-09

    Sermorelin Acetate Vials Recalled for Lack of Sterility Assurance

    KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.

    Product
    Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2644-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 353 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.5 SH, .070", REF SA6JR35SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0023-2020·2019-10-09

    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/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0020-2020·2019-10-09

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

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

    Product
    C-PAPAV/PHENTOL/PGE1 10MG/1MG/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-0081-2020·2019-10-09

    KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 185 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 MAC 3.5, .070", REF SA6MAC35. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0106-2020·2019-10-09

    KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns

    KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.

    Product
    Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0115-2020·2019-10-09

    KRS Global Biotechnology Recalls IV Vitamin B12 Vials for Sterility Concerns

    KRS Global Biotechnology is recalling 948 vials of IV Vitamin B12 products due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 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 3321678335
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2666-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 129 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 EBU3.0 SH, .070", REF SA6EBU30SH. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0124-2020·2019-10-09

    Torrent Pharma Recalls Losartan Potassium/Hydrochlorothiazide Tablets Due to Impurity

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

    Product
    Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0074-2020·2019-10-09

    KRS Global Biotechnology Recalls IV Magnesium and Calcium Vials for Sterility Concerns

    KRS Global Biotechnology is recalling 878 vials of IV magnesium and calcium solution due to a lack of assurance of sterility.

    Product
    Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2568-2019·2019-10-09

    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, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0102-2020·2019-10-09

    KRS Global Biotechnology Recalls Sodium Citrate and Gentamicin Vials

    KRS Global Biotechnology is recalling 150 vials of Sodium Citrate and Gentamicin solution due to a lack of assurance of sterility.

    Product
    Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2020·2019-10-09

    KRS Global Biotechnology Recalls ePHEDrine Sulfate Syringes Due to Sterility Concerns

    KRS Global Biotechnology is recalling ePHEDrine Sulfate syringes nationwide because the company cannot guarantee the product is sterile.

    Product
    ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2020·2019-10-09

    Colonia Care Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns

    Colonia Care Pharmacy is recalling specific vials of Calcium Gluconate 1% Injection because the sterility of the product cannot be guaranteed.

    Product
    C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0012-2020·2019-10-09

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

    Colonia Care Pharmacy is recalling C-Hydroxocobalamin 5 mg/mL injection syringes because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.

    Product
    C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·19V724000·2019-10-09

    Volvo Bus 9700 Recalled for Insufficient Seat Belt Anchorages

    Volvo Bus is recalling 2018-2020 9700 models because passenger seat belt attachments may not anchor properly, increasing injury risk in crashes.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2575-2019·2019-10-09

    Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss

    Medtronic Vascular is recalling 5 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.

    Product
    SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
    Category
    Medical Device
    Distribution
    0 states

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