October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical: 64
Severe: 328
High: 307
Moderate: 88
Low: 20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 41% are Severe.

Which agencies issued them

501–600 of 807

SevereFDA (Drugs)·D-0047-2020·2019-10-09
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) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374
Category
Drug
Distribution
Distributed nationwide
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 (Drugs)·D-0116-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 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, F
Category
Drug
Distribution
Distributed nationwide
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 (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 33487
Category
Drug
Distribution
Distributed nationwide
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-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 (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-0014-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Hydroxyprogesterone Caproate Injections for Sterility Concerns
Colonia Care Pharmacy is recalling 18 vials of C-Hydroxyprogesterone Caproate 250mg/mL injections because the sterility of the product cannot be guaranteed.
Product
C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 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-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-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 (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-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-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-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 (Drugs)·D-0122-2020·2019-10-09
Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 mg because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0078-2020·2019-10-09
KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.
Product
NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 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 3321678303
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2662-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 102 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 JR3.0, .070", REF SA6JR30. for cardiovascular use
Category
Medical Device
Distribution
0 states
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-0004-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Albumin 5% Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.
Product
C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
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-0092-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.
Product
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
Category
Drug
Distribution
Distributed nationwide
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-0084-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.
Product
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0101-2020·2019-10-09
Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
Product
Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
Category
Drug
Distribution
Distributed nationwide
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-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-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 (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 (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-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-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 (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 (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 3
Category
Drug
Distribution
Distributed nationwide
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 (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 (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
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-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 (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 (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-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 (Drugs)·D-0059-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,263 vials of Human Chorionic Gonadotropin 6,000 Units due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969
Category
Drug
Distribution
Distributed nationwide
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-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 (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 (Devices)·Z-2615-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 6F Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0026-2020·2019-10-09
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/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-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 (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 (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 (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 (Drugs)·D-0057-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,871 vials of Human Chorionic Gonadotropin 20,000 Units due to a lack of assurance of sterility.
Product
Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0069-2020·2019-10-09
KRS Global Biotechnology Recalls Lidocaine HCl Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl 2% syringes nationwide due to a lack of assurance of sterility. The recall affects 4,450 syringes.
Product
LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 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 33487NDC 3321678315
Category
Drug
Distribution
Distributed nationwide
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 (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 (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 (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-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-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-0077-2020·2019-10-09
KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 7,685 vials of Neostigmine Methylsulfate due to a lack of assurance of sterility. The recall is nationwide.
Product
NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847
Category
Drug
Distribution
Distributed nationwide
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-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-0033-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Urea 40% Bladder Instill Due to Sterility Concerns
Colonia Care Pharmacy is recalling 7 vials of C-Urea 40% Bladder Instill because the product's sterility cannot be guaranteed.
Product
C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
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 (Devices)·Z-0037-2020·2019-10-09
Quality Electrodynamics Recalls Siemens Knee and Extremity MRI Coils
Quality Electrodynamics LLC is recalling 21 Siemens MRI coils due to potential ferrous material in the pushbutton assembly.
Product
TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
Category
Medical Device
Distribution
1 state
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-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 (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 (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-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 (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 (Drugs)·D-0046-2020·2019-10-09
KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 3,895 syringes of ephedrine sulfate due to a lack of assurance of sterility. The product was distributed nationwide.
Product
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0097-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling 152 cartridges of Sermorelin Acetate 9 mg/3 mL nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Category
Drug
Distribution
Distributed nationwide
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 (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 (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-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 (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 (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 (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-0096-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.
Product
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
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-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 (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 (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 Bl
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0029-2020·2019-10-09
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. The recall affects patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereNHTSA·19V720000·2019-10-09
Hyundai Recalls 2019 Ioniq Hybrid and 2020 Elantra for Wheel Lug Nut Issue
Hyundai is recalling 2019 Ioniq Hybrid and 2020 Elantra vehicles because right-side rear wheel lug nuts may be insufficiently tightened, posing a crash risk.
Product
HYUNDAI — HYUNDAI IONIQ HYBRID, ELANTRA
Category
Vehicle
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 (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 (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-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 (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-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 (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 (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 (Devices)·Z-2674-2019·2019-10-09
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 ERAD LEFT, LONG TIP, .070", REF SA6ERADLLT. for cardiovascular use
Category
Medical Device
Distribution
0 states
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

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