The Recall Desk

Archive

November 2015 recalls

745 recalls were announced in November 2015.

What the numbers show

Critical
22
Severe
397
High
235
Moderate
76
Low
15

Of the 745 recalls this month scored against our rubric, 3% are Critical, 53% are Severe.

Which agencies issued them

601–700 of 745

  • SevereFDA (Drugs)·D-0110-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling methylcobalamin/hydroxocobalamin syringes because the company cannot ensure the products are sterile.

    Product
    METHYLCOBALAMIN/HYDROXOCOBALAMIN PRESERVATIVE FREE UNIT DOSE SYRINGES, Injectable Solution, 2.5/0. 5MG/ML, 20 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0158-2016·2015-11-04

    Park Compounding Pharmacy Recalls TRI-MIX Vials Due to Sterility Concerns

    Park Compounding Pharmacy is recalling specific lots of TRI-MIX vials because the agency could not ensure the products were sterile.

    Product
    TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0156-2016·2015-11-04

    Park Compounding Pharmacy Recalls Prostaglandin PGE-1 Due to Sterility Concerns

    Park Compounding Pharmacy is recalling specific vials of Prostaglandin PGE-1 because the agency could not ensure the products remained sterile.

    Product
    PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0120-2016·2015-11-04

    FDA Recalls Sermorelin Injectable Solution Due to Sterility Concerns

    FDA is recalling Sermorelin/GHRP-6/GHRP-2 injectable solution from Moses Lake Professional Pharmacy due to lack of assurance of sterility.

    Product
    SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 4.5/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0113-2016·2015-11-04

    Moses Lake Pharmacy Recalls Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling a compounded injectable solution because the FDA could not ensure the product remained sterile. Patients should stop using the medication and contact their healthcare provider.

    Product
    PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 30 MG/2 MG/0. 1MG/20MCG, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0059-2016·2015-11-04

    Moses Lake Pharmacy Recalls Injectable Vitamin and Amino Acid Solution

    Moses Lake Professional Pharmacy is recalling 22 vials of a compounded injectable solution due to a lack of assurance of sterility.

    Product
    B1/B2/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/5/1/10/25/8/17/17 MG/ML, 30 mM vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0103-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling specific syringes of Methylcobalamin injectable solution because the agency could not ensure the product remained sterile.

    Product
    METHYLCOBALAMIN, injectable Solution, 10 MG/ML, syringe sizes: 10mL; 22.5mL; and 30mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0118-2016·2015-11-04

    FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns

    The FDA is recalling compounded progesterone pellets from Moses Lake Professional Pharmacy because the agency cannot ensure the products are sterile.

    Product
    PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0100-2016·2015-11-04

    Moses Lake Pharmacy Recalls Hydroxyprogesterone Caproate Oil Due to Sterility Concerns

    JD & SN Inc. is recalling specific syringes of Hydroxyprogesterone Caproate Oil because the FDA cannot ensure the sterile compounded drugs are free from contamination.

    Product
    HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0104-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

    JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Methylcobalamin Injectable Solution because the agency cannot assure the sterility of the compounded drug.

    Product
    METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0065-2016·2015-11-04

    Moses Lake Pharmacy Recalls Chorionic Gonadotropin Due to Sterility Concerns

    JD & SN Inc. is recalling specific vials of Chorionic Gonadotropin injectable solution because the agency could not ensure the sterile human compounded drugs were sterile.

    Product
    CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0089-2016·2015-11-04

    Moses Lake Pharmacy Recalls Sterile Ethyl Alcohol Syringes Due to Sterility Concerns

    JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 30 mL syringes of 100% sterile ethyl alcohol for injection due to a lack of assurance of sterility.

    Product
    ETHYL ALCOHOL (STERILE FOR INJECTION) 100%, Injectable Solution, 200 PROOF, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0121-2016·2015-11-04

    Moses Lake Professional Pharmacy Recalls Sermorelin Injectable Solution

    Moses Lake Professional Pharmacy is recalling 165 syringes of Sermorelin/GHRP-6/GHRP-2 injectable solution due to a lack of assurance of sterility.

    Product
    SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0081-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Moses Lake Professional Pharmacy is recalling Estradiol 20 mg pellets because the FDA determined there is a lack of assurance of sterility.

    Product
    ESTRADIOL, Pellet, 20 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0124-2016·2015-11-04

    Moses Lake Professional Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 298 units of compounded testosterone pellets because the FDA cannot ensure the product is sterile.

    Product
    TESTOSTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 130 mg testosterone pellets because the company cannot ensure they are sterile.

    Product
    TESTOSTERONE, Pellet, 130 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0084-2016·2015-11-04

    Moses Lake Professional Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Estradiol 30 mg pellets because the company cannot ensure the products are sterile.

    Product
    ESTRADIOL, Pellet, 30 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0129-2016·2015-11-04

    FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    FDA is recalling specific lots of compounded testosterone pellets because the manufacturer cannot ensure sterility. Patients should contact their healthcare provider.

    Product
    TESTOSTERONE, Pellet, 115 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0127-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 51 testosterone pellets nationwide because the FDA determined there is a lack of assurance of sterility.

    Product
    TESTOSTERONE, Pellet, 110 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0114-2016·2015-11-04

    FDA Recalls Papaverine/Phentolamine/Prostaglandin Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling 2 syringes of Papaverine/Phentolamine/Prostaglandin Injectable Solution because the agency cannot assure the sterility of the compounded drug.

    Product
    PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/10 MCG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling preservative-free methylcobalamin injectable solution due to a lack of assurance of sterility.

    Product
    METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution, 15 MG/ML, syringe size: 12 mL, 20 mL, 30 mL, 40 mL, 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2016·2015-11-04

    Moses Lake Pharmacy Recalls Alprostadil/Procaine Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling 150 vials of Alprostadil/Procaine Injectable Solution due to a lack of assurance of sterility.

    Product
    ALPROSTADIL/PROCAINE, Injectable Solution, 20 MCG/0.1%/ML, 10 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2016·2015-11-04

    Moses Lake Professional Pharmacy Recalls Injectable Vitamin and Lidocaine Solution

    JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 30 mL vials of an injectable solution containing vitamins, lidocaine, and other compounds due to a lack of assurance of sterility.

    Product
    B1/B2/B3/B5/B12/LIDOCAINE/ISOLEUCINE/METHIONINE/CHOLINE/INOSITOL, Injectable Solution, 50/5/50/5/1/10/25/8/17/17 MG/ML, 30 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0069-2016·2015-11-04

    FDA Recalls Compounded Chorionic Gonadotropin Syringes Due to Sterility Concerns

    FDA is recalling 40 syringes of compounded chorionic gonadotropin from Moses Lake Professional Pharmacy due to lack of assurance of sterility.

    Product
    CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 250 UNITS/0.25ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0066-2016·2015-11-04

    FDA Recalls Compounded Chorionic Gonadotropin Syringes Due to Sterility Concerns

    FDA is recalling 42 syringes of compounded chorionic gonadotropin from Moses Lake Professional Pharmacy due to lack of assurance of sterility.

    Product
    CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 150 UNITS/0.150 ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2016·2015-11-04

    Moses Lake Pharmacy Recalls Vitamin B-Complex Injectable Solution

    JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Vitamin B-Complex Injectable Solution due to a lack of assurance of sterility.

    Product
    VITAMIN B-COMPLEX, Injectable Solution, Syringe size: 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0109-2016·2015-11-04

    FDA Recalls Methylcobalamin Injectable Syringes Due to Sterility Concerns

    The FDA is recalling 36 syringes of Methylcobalamin Injectable Solution because the manufacturer cannot ensure the product is sterile.

    Product
    METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution,1 mg/mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0092-2016·2015-11-04

    FDA Recalls Compounded Injectable Glutathione Due to Sterility Concerns

    FDA is recalling compounded injectable glutathione from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.

    Product
    GLUTATHIONE MDV, Injectable Solution, 200 mg/mL, syringe sizes: 60 mL, 90 mL; 100 mL; and 150 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0137-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 70 mg testosterone pellets because the company cannot guarantee the sterility of the compounded drug.

    Product
    TESTOSTERONE, Pellet, 70 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0061-2016·2015-11-04

    FDA Recalls Chorionic Gonadotropin Vials Due to Sterility Concerns

    The FDA is recalling 9 vials of Chorionic Gonadotropin Injectable Solution from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.

    Product
    CHORIONIC GONADOTROPIN, Injectable Solution, 4000 UNITS/ mL, 8 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2016·2015-11-04

    Siemens Medical Solutions Recalls 158 Radiation Therapy Machines

    Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.

    Product
    ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2016·2015-11-04

    Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors

    Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.

    Product
    Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0169-2016·2015-11-04

    Welch Allyn KleenSpec Corded Illuminator Recalled for Electric Shock Risk

    Welch Allyn is recalling KleenSpec Corded Illuminators because they may be connected to AC power, posing a shock hazard.

    Product
    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0094-2016·2015-11-04

    Moses Lake Pharmacy Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling two syringes of Glycopyrrolate Injectable Solution because the company cannot guarantee the product is sterile.

    Product
    GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2016·2015-11-04

    Moses Lake Pharmacy Recalls Folic Acid Injectable Solution Due to Sterility Concerns

    JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling six syringes of Folic Acid Injectable Solution because the sterility of the compounded drug cannot be assured.

    Product
    FOLIC ACID, Injectable Solution, 10 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0106-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling Methylcobalamin MDV Injectable Solution due to a lack of assurance of sterility. The recall covers all sterile human compounded drugs within their expiry dates.

    Product
    METHYLCOBALAMIN MDV, Injectable Solution, 2 MG/ML, 10mL syringe; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0134-2016·2015-11-04

    FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    JD & SN Inc. is recalling 25 mg testosterone pellets because the agency cannot ensure the sterile compounded drugs are free from contamination.

    Product
    TESTOSTERONE, Pellet, 25 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0120-2016·2015-11-04

    Protein Powder Recalled for Undeclared Soy and Milk Allergens

    American Pure Whey is recalling Build Your Own Body Protein Powder due to undeclared soy and milk allergens.

    Product
    Build Your Own Body, Protein Powder, Manufactured for Build Your Own Body, Flagstaff Arizona.
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Drugs)·D-0115-2016·2015-11-04

    Moses Lake Pharmacy Recalls Procaine MDV Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling Procaine MDV Injectable Solution due to a lack of assurance of sterility. The recall covers 30mL and 300mL containers distributed nationwide.

    Product
    PROCAINE MDV, Injectable Solution,1%, container sizes: 30mL and 300mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0102-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methionine/Choline/Inositol Injectable Solution

    Moses Lake Professional Pharmacy is recalling Methionine/Choline/Inositol injectable solution due to a lack of assurance of sterility.

    Product
    METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0146-2016·2015-11-04

    FDA Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

    FDA is recalling Testosterone/Anastrozole pellets from Moses Lake Professional Pharmacy because the agency cannot ensure the sterile compounded drugs are sterile.

    Product
    TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0160-2016·2015-11-04

    Park Compounding Pharmacy Recalls TRI-MIX Vials Due to Sterility Concerns

    Park Compounding Pharmacy is recalling 2 vials of TRI-MIX 20MCG+0.5MG+15MG/ML due to a lack of assurance of sterility. The recall affects products distributed in California.

    Product
    TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0101-2016·2015-11-04

    Moses Lake Pharmacy Recalls Medroxyprogesterone Acetate Syringes Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling 11 syringes of Medroxyprogesterone Acetate because the FDA determined there is a lack of assurance of sterility.

    Product
    MEDROXYPROGESTERONE ACETATE, injectable Solution,150MG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0073-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Injectable Cyanocobalamin Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling 30 syringes of compounded injectable cyanocobalamin because the product lacks assurance of sterility.

    Product
    CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0098-2016·2015-11-04

    FDA Recalls Hydroxocobalamin Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling Hydroxocobalamin Injectable Solution because the agency cannot ensure the product is sterile. Patients should stop using the product and contact their healthcare provider.

    Product
    HYDROXOCOBALAMIN MULTIDOSE VIAL, Injectable Solution, 5 mg/mL, syringe sizes: 6 mL, 10 mL, 30 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0077-2016·2015-11-04

    Moses Lake Pharmacy Recalls EDETATE CALCIUM DISODIUM Injectable Solution

    JD & SN Inc. is recalling EDETATE CALCIUM DISODIUM Injectable Solution due to a lack of assurance of sterility.

    Product
    EDETATE CALCIUM DISODIUM (SINGLE USE ONLY), Injectable Solution, 300 mg/mL, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    JD & SN Inc. is recalling Estradiol 18 mg pellets because the company cannot assure the sterility of the product. The recall covers all sterile human compounded drugs within their expiry date.

    Product
    ESTRADIOL, Pellet, 18 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0151-2016·2015-11-04

    Moses Lake Pharmacy Recalls Trimix Injectable Solution Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling Trimix injectable solution because the FDA cannot assure the sterility of the compounded drug.

    Product
    TRIMIX, injectable Solution, 30MG/2MG/20MCG, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0064-2016·2015-11-04

    Moses Lake Pharmacy Recalls Chorionic Gonadotropin Due to Sterility Concerns

    JD & SN Inc. is recalling specific vials of Chorionic Gonadotropin because the FDA cannot assure the sterility of the compounded drug.

    Product
    CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0144-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Propionate Injectable Solution

    JD & SN Inc. is recalling 5 syringes of Testosterone Propionate Injectable Solution due to a lack of assurance of sterility.

    Product
    TESTOSTERONE PROPRIONATE, Injectable Solution, 100 mg/mL, syringe size: 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0057-2016·2015-11-04

    FDA Recalls Alprostadil/Procaine Injectable Solution Due to Sterility Concerns

    The FDA is recalling 27 vials of Alprostadil/Procaine Injectable Solution because the manufacturer cannot ensure the product is sterile.

    Product
    ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Testosterone Cypionate Injectable Solution

    Moses Lake Professional Pharmacy is recalling compounded Testosterone Cypionate injectable solution due to a lack of assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 5mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0136-2016·2015-11-04

    FDA Recalls Testosterone Pellets Due to Lack of Sterility Assurance

    FDA is recalling specific lots of compounded testosterone pellets because they lack assurance of sterility. Patients should contact their healthcare provider.

    Product
    TESTOSTERONE, Pellet, 60 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0131-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 120 mg testosterone pellets because the company cannot ensure the sterile compounded drugs are free from contamination.

    Product
    TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0097-2016·2015-11-04

    FDA Recalls Compounded Hydroxocobalamin Injectable Solution Due to Sterility Concerns

    The FDA is recalling compounded hydroxocobalamin injectable solution from Moses Lake Professional Pharmacy due to a lack of assurance of sterility.

    Product
    HYDROXOCOBALAMIN (COMPOUNDED), Injectable Solution, 1 mg/mL, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0088-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    The FDA is recalling Estradiol pellets compounded by Moses Lake Professional Pharmacy because the firm cannot assure the sterility of the product.

    Product
    ESTRADIOL, Pellet, 9 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0090-2016·2015-11-04

    FDA Recalls Compounded Folic Acid Injectable Solution Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling compounded folic acid injectable solution because the agency cannot assure the product is sterile.

    Product
    FOLIC ACID (COMPOUNDED), Injectable Solution, 5 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2016·2015-11-04

    FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling compounded progesterone pellets because the agency cannot ensure they are sterile. Consumers should stop using the product and contact their healthcare provider.

    Product
    PROGESTERONE, Pellet, 200 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0130-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 116 mg testosterone pellets because the agency could not ensure the sterile compounded drugs were sterile.

    Product
    TESTOSTERONE, Pellet, 116 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0142-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling Testosterone Cypionate for Subcutaneous Injection because the product lacks assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 100 mg/mL, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0159-2016·2015-11-04

    Park Compounding Pharmacy Recalls Caffeine and Sodium Benzoate Vials

    Park Compounding Pharmacy is recalling specific vials of Caffeine + Sodium Benzoate 500mg/mL due to a lack of assurance of sterility.

    Product
    CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0112-2016·2015-11-04

    FDA Recalls Injectable Solution Due to Lack of Sterility Assurance

    FDA is recalling a compounded injectable solution due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    PAPAVERINE/PHENTOLAMINE/ATROPINE/PROSTAGLANDIN, Injectable Solution, 9 MG/1 MG/0. 1MG/10MCG/ML, syringe 10 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0078-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    JD & SN Inc. is recalling Estradiol pellets because the FDA determined there is a lack of assurance of sterility for all sterile human compounded drugs within their expiry.

    Product
    ESTRADIOL, Pellet, 12.5 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0154-2016·2015-11-04

    Moses Lake Pharmacy Recalls Vitamin D3 Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling 4 syringes of Vitamin D3 Oil Injectable Solution due to a lack of assurance of sterility.

    Product
    VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0149-2016·2015-11-04

    Moses Lake Pharmacy Recalls TRIMIX Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling TRIMIX injectable solution because the agency could not ensure the product remained sterile. Patients should stop using the medication and contact their healthcare provider.

    Product
    TRIMIX, injectable Solution, 30MG/1MG/10MCG, syringe sizes: 5 mL and 10mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0105-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling specific syringes of Methylcobalamin Injectable Solution because the FDA cannot assure the sterility of the compounded drug.

    Product
    METHYLCOBALAMIN MDV, Injectable Solution, 1 MG/ML, syringe sizes: 4 mL; 10 mL; 12 mL; 15mL; 30 mL; 50 mL; and 60 mL, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0074-2016·2015-11-04

    Moses Lake Pharmacy Recalls Dexpantenol Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling 6 syringes of Dexpantenol Injectable Solution because the FDA identified a lack of assurance of sterility.

    Product
    DEXPANTHENOL, Injectable Solution, 250 MG/ML, 30 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0145-2016·2015-11-04

    FDA Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling Testosterone/Anastrozole pellets because the FDA identified a lack of assurance of sterility for the compounded drugs.

    Product
    TESTOSTERONE/ANASTROZOLE, Pellet, 120/8 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0062-2016·2015-11-04

    Moses Lake Pharmacy Recalls Chorionic Gonadotropin Vials Due to Sterility Concerns

    JD & SN Inc. is recalling 95 vials of Chorionic Gonadotropin because the FDA could not verify the sterility of the compounded drug.

    Product
    CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0071-2016·2015-11-04

    FDA Recalls Chorionic Gonadotropin/Cyanocobalamin Injectable Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling 42 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution due to a lack of assurance of sterility.

    Product
    CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 1000 units/1 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    Moses Lake Professional Pharmacy is recalling Estradiol Pellets because the FDA determined there is a lack of assurance of sterility for the compounded drug.

    Product
    ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns

    JD & SN Inc. is recalling 184 syringes of compounded chorionic gonadotropin nationwide because the FDA could not ensure the product was sterile.

    Product
    CHORIONIC GONADOTROPIN COMPOUNDED, Injectable Solution, 200 UNITS/0.2ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0086-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    The FDA is recalling Estradiol Pellets, 6 mg, compounded by JD & SN Inc. because the agency cannot assure the sterility of the product.

    Product
    ESTRADIOL, Pellet, 6 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0125-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 92 testosterone pellets because the company cannot ensure they are sterile. The recall covers products distributed nationwide.

    Product
    TESTOSTERONE, Pellet, 100 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2016·2015-11-04

    LifeHealth Recalls IRMA TRUPOINT Blood Gas Analyzer CC Cartridges

    LifeHealth, LLC is recalling IRMA TRUPOINT Blood Gas Analyzer CC Cartridges because the pH sensor may provide falsely elevated results as shelf life progresses.

    Product
    CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2016·2015-11-04

    Resource Optimization Recalls 28 Custom Cardiovascular Surgical Kits

    Resource Optimization & Innovation LLC is recalling 28 custom cardiovascular surgical kits because a component had compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0163-2016·2015-11-04

    Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

    Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

    Product
    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0099-2016·2015-11-04

    Goya Recalls Kirby Spanish Barbecue Sauce for Undeclared Peanut

    Goya Foods is recalling Kirby Spanish Barbecue Sauce Mojo Criollo because an ingredient supplier reported potential undeclared peanut protein in the cumin used.

    Product
    Kirby Spanish Barbecue Sauce Mojo Criollo (a) 24 ounce and (c) 1 Gallon; Packed For Kirby Foods, Inc. Miami, Florida 33172; Product of Dominican Republic
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0162-2016·2015-11-04

    Materialise Recalls Patient-Specific Knee Surgical Guides Due to Alignment Inaccuracies

    Materialise N.V. is recalling four patient-specific surgical guides for knee arthroplasty because image data processing errors led to inaccurate surgical planning.

    Product
    Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0107-2016·2015-11-04

    Kermit's P4 Hot Sauce Recalled for Undeclared Soy Allergen

    Kermit, Inc. is recalling Kermit's P4 Hot Sauce because the product label fails to declare soy, a major food allergen.

    Product
    Kermit's P4 Hot Sauce, 5.5 oz, Key West, FL, UPC 020108012019 & 802468905701
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2016·2015-11-04

    Moonstruck Chocolate Nuts and Chews Recalled for Undeclared Sulfite

    Moonstruck Chocolate Company is recalling 253 boxes of 9pc Nuts & Chews Collection due to undeclared sulfite. The product was distributed in 14 states and online.

    Product
    Moonstruck Chocolates 9 piece Nuts & Chews Collection. The box contains 9 different nut and chews, various shapes, in 9 different flavors. Net Wt. 5.19oz (147g). Item Number: 310896, UPC: 7 11175 10896 4.
    Category
    Food
    Distribution
    14 states
  • HighNHTSA·15V729000·2015-11-04

    MobilityWorks Recalls Ford Vans with Defective Ricon Wheelchair Lifts

    MobilityWorks is recalling 667 Ford E-series vans equipped with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to shift, causing the lift platform to fall and injure the operator.

    Product
    FORD — FORD E-250, E-150, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0108-2016·2015-11-04

    Kermit's Key Lime Ginger Wasabi Marinade Recalled for Undeclared Soy and Wheat

    Kermit, Inc. is recalling 455 bottles of Key Lime Ginger Wasabi Marinade because the label fails to list soy and wheat ingredients.

    Product
    Kermit's Key Lime Ginger Wasabi Marinade, 12 oz, Key West, FL, UPC 070820060706 & 802468905480
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0117-2016·2015-11-04

    American Pure Whey Protein Recalled for Undeclared Soy and Milk Allergens

    American Pure Whey is recalling Whey Protein Matrix Chocolate flavor containers due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Matrix Chocolate flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-0116-2016·2015-11-04

    Foods R US Recalls Breaded Ravioli for Undeclared Allergens

    Foods R US is recalling Breaded Ravioli due to undeclared soy, milk, and wheat. The product was distributed in California and Arizona.

    Product
    Breaded Ravioli 10 lb. Mfg Foods R Us Scottsdale, AZ 85260 480-951-1883
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0185-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0186-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 77 custom cardiovascular surgical kits because a component's compromised packaging may affect sterility assurance.

    Product
    Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0179-2016·2015-11-04

    Encore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 277 Turon Shoulder Impaction Fixtures because polymer material wore off during assembly, potentially contaminating the implant.

    Product
    Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to ass
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2016·2015-11-04

    Pfizer Recalls Subpotent Xanax Alprazolam Tablets Nationwide

    Pfizer is voluntarily recalling 21,120 bottles of Xanax (alprazolam) 0.25 mg tablets because the medication contains less active ingredient than labeled.

    Product
    XANAX — XANAX (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0103-2016·2015-11-04

    Kermit's Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Sweet & Tasty Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 011550150134 & 802468905411
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2016·2015-11-04

    FDA Recalls Custom Surgical Kits Due to Compromised Sterility Assurance

    Resource Optimization & Innovation LLC is recalling 17 custom surgical kits in Texas and Louisiana because a component was recalled for compromised package integrity, potentially affecting sterility.

    Product
    Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0122-2016·2015-11-04

    American Pure Whey Protein Isolate Recalled for Undeclared Soy and Milk

    American Pure Whey is recalling Whey Protein Isolate (Vanilla flavor) due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Isolate (Vanilla flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0118-2016·2015-11-04

    Siemens CIOS ALPHA Fluoroscopic X-Ray System Recalled for Potential Failure

    Siemens Medical Solutions is recalling 44 CIOS ALPHA fluoroscopic x-ray systems due to a potential system failure that could interrupt patient procedures.

    Product
    CIOS ALPHA; image intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2016·2015-11-04

    Philips Recalls Brilliance Big Bore CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 268 Brilliance Big Bore CT systems worldwide due to X-ray measurement errors causing image artifacts.

    Product
    Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 13 vials of 80 mg testosterone pellets because the FDA cannot ensure the sterile compounded drugs are free from contamination.

    Product
    TESTOSTERONE, Pellet, 80 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0102-2016·2015-11-04

    Kermit's Key Lime Steak Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 10-ounce bottles of Key Lime Steak Sauce because the label fails to list soy as an ingredient.

    Product
    Kermit's Key Lime Steak Sauce, 10 oz, Key West, FL, UPC 231920085093
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2016·2015-11-04

    LifeHealth Recalls BG Cartridges for IRMA TRUPOINT Blood Gas Analyzer

    LifeHealth is recalling BG cartridges for the IRMA TRUPOINT Blood Gas Analyzer because the pH sensor may provide falsely elevated results as the product ages.

    Product
    BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2016·2015-11-04

    Kermit's Chipotle Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Chipotle Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Chipotle Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 091920850929
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0104-2016·2015-11-04

    Kermit's Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16-ounce bottles of Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Medium Mannered Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501409
    Category
    Food
    Distribution
    Distributed nationwide

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