The Recall Desk

Archive

November 2015 recalls

745 recalls were announced in November 2015.

What the numbers show

Critical
22
Severe
417
High
215
Moderate
76
Low
15

Of the 745 recalls this month scored against our rubric, 3% are Critical, 56% are Severe.

Which agencies issued them

601–700 of 745

  • 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-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-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-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-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-0111-2016·2015-11-04

    FDA Recalls Papaverine and Phentolamine Injectable Solution Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling 8 syringes of Papaverine/Phentolamine Injectable Solution because the agency cannot assure the sterility of the compounded drug.

    Product
    PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/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-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-0123-2016·2015-11-04

    FDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns

    FDA is recalling 100 syringes of Sodium Tetradecyl Sulfate Injectable Solution 3% due to lack of assurance of sterility.

    Product
    SODIUM TETRADECYL SULFATE, Injectable Solution, 3%, 2 mL syringe, Rx only, JD & SN Inc, 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-0079-2016·2015-11-04

    FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance

    The FDA is recalling Estradiol 12 mg pellets from Moses Lake Professional Pharmacy because the manufacturer cannot ensure the sterile compounded drugs are sterile.

    Product
    ESTRADIOL, Pellet, 12 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-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-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-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-0148-2016·2015-11-04

    Moses Lake Pharmacy Recalls TRIMIX Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling 155 syringes of TRIMIX injectable solution nationwide due to a lack of assurance of sterility.

    Product
    TRIMIX, injectable Solution, 20MG/1MG/20MCG/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-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-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 (Devices)·Z-0188-2016·2015-11-04

    FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • 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-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-0095-2016·2015-11-04

    Moses Lake Pharmacy Recalls Hydroxocobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling 11 Hydroxocobalamin syringes because the FDA cannot ensure they are sterile. The recall covers units distributed nationwide.

    Product
    HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 1.5 mg/0.25 mL, 20 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-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-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-0138-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 18-pellet vials of 76 mg Testosterone Pellets because the FDA determined there is a lack of assurance of sterility.

    Product
    TESTOSTERONE, Pellet, 76 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-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-0128-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 91 vials of compounded testosterone pellets because the FDA cannot assure the sterility of the product.

    Product
    TESTOSTERONE, Pellet, 112 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-0060-2016·2015-11-04

    Moses Lake Pharmacy Recalls Compounded Vitamin Injectable Solution

    JD & SN Inc. is recalling compounded vitamin injectable solutions due to a lack of assurance of sterility.

    Product
    CALM ME VITAMIN COCKTAIL, MAGNESIUM, COMPOUNDED B COMPLEX, Injectable Solution, 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-0152-2016·2015-11-04

    Moses Lake Pharmacy Recalls Trimix Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling 3 syringes of Trimix injectable solution because the FDA could not ensure the drug was sterile.

    Product
    TRIMIX, injectable Solution, 40MG/2MG/40MCG/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-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-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-0072-2016·2015-11-04

    FDA Recalls Chorionic Gonadotropin/Cyanocobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling 26 syringes of Chorionic Gonadotropin/Cyanocobalamin Injectable Solution nationwide due to a lack of assurance of sterility.

    Product
    CHORIONIC GONADOTROPIN/CYANOCOBALAMIN, Injectable Solution, 2000 unit/1mg/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-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-0082-2016·2015-11-04

    Moses Lake Pharmacy Recalls Estradiol Syringes Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling estradiol injectable syringes because the company cannot guarantee they are sterile.

    Product
    ESTRADIOL, Injectable Solution, 20 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-0116-2016·2015-11-04

    FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns

    The FDA is recalling compounded progesterone pellets from JD & SN Inc. because the manufacturer cannot guarantee the products are sterile.

    Product
    PROGESTERONE, 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
  • 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-0076-2016·2015-11-04

    Moses Lake Pharmacy Recalls DMPS Injectable Solution Due to Sterility Concerns

    JD & SN Inc. is recalling DMPS injectable solution because the FDA cannot ensure the product is sterile. Patients should stop using the medication and contact their healthcare provider.

    Product
    DMPS (DIMERCAPTO-PROPANESULFONIC NA (SINGLE USE ONLY), Injectable Solution, 500 mg/mL, 5mL 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 (Food)·F-0124-2016·2015-11-04

    Sunkist Frozen Mango Sorbet Bars Recalled for Undeclared Milk

    Dean Foods is recalling Sunkist Frozen Mango Fruit Sorbet Bars because they contain undeclared milk, a major allergen.

    Product
    Sunkist Frozen Mango Fruit Sorbet Bar 6 x 2.5 FL OZ. (74 mL) Bars/ 15 FL OZ (444 mL) and pint (473 mL) UPC: 51819-00303
    Category
    Food
    Distribution
    2 states
  • 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-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 (Food)·F-0121-2016·2015-11-04

    American Pure Whey Protein Recalled for Undeclared Soy and Milk Allergens

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

    Product
    American Pure Whey, Whey Protein Matrix Vanilla flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • 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-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
  • 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-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-0075-2016·2015-11-04

    Moses Lake Pharmacy Recalls Dihydroergotamine Mesylate Injectable Syringes

    JD & SN Inc. is recalling 8 syringes of Dihydroergotamine Mesylate Injectable Solution due to a lack of assurance of sterility.

    Product
    DIHYDROERGOTAMINE MESYLATE, Injectable Solution, 1 MG/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 (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 (Drugs)·D-0096-2016·2015-11-04

    Moses Lake Pharmacy Recalls Hydroxocobalamin Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling Hydroxocobalamin syringes because the FDA cannot assure the products are sterile.

    Product
    HYDROXOCOBALAMIN (PRESERVATIVE FREE) UNIT DOSE SYRINGES, Injectable Solution, 3 mg/0.25 mL, syringe sizes: 20 mL and 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-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 (Food)·F-0118-2016·2015-11-04

    American Pure Whey Protein Isolate Recalled for Undeclared Soy and Milk

    American Pure Whey is recalling Whey Protein Isolate (Chocolate flavor) in 2 lb. and 5 lb. containers due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Isolate (Chocolate flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • 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 (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 (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
  • SevereFDA (Drugs)·D-0083-2016·2015-11-04

    Moses Lake Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling Estradiol 25 mg pellets because the agency cannot assure the sterility of the compounded drug.

    Product
    ESTRADIOL, 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 (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
  • 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-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-0107-2016·2015-11-04

    Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution for Sterility Concerns

    JD & SN Inc. is recalling 6 syringes of Methylcobalamin Injectable Solution due to a lack of assurance of sterility. The recall covers all sterile human compounded drugs within their expiry.

    Product
    METHYLCOBALAMIN MDV, Injectable Solution, 5 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-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-0122-2016·2015-11-04

    Moses Lake Pharmacy Recalls Sermorelin Injectable Solution Due to Sterility Concerns

    Moses Lake Professional Pharmacy is recalling 41 syringes of Sermorelin/GHRP-6/GHRP-2 injectable solution because the FDA cannot assure the sterility of the compounded drug.

    Product
    SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/9/9MG/9ML, 9 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-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 (Food)·F-0097-2016·2015-11-04

    Trader Joe's Coconut Cranberry Granola Recalled for Undeclared Allergens

    New England Natural Bakers is recalling Trader Joe's Coconut Cranberry Granola because it may contain undeclared milk, wheat, and pecans.

    Product
    Trader Joes Coconut Cranberry Granola (SKU 51131), packaged in a 16 oz. box, with Best By date 08/19/16 printed at the top of the package UPC Code: 0051 1315 printed on side panel.
    Category
    Food
    Distribution
    19 states
  • 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-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-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-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-0093-2016·2015-11-04

    FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns

    FDA is recalling 2 syringes of injectable glutathione from Moses Lake Professional Pharmacy because the sterility of the compounded drug cannot be assured.

    Product
    GLUTATHIONE (L), Injectable Solution, 75 mg/mL, 64 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 (Devices)·Z-0191-2016·2015-11-04

    Resource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect sterility.

    Product
    Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states
  • 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-0140-2016·2015-11-04

    Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    JD & SN Inc. is recalling 90 mg testosterone pellets because the agency could not ensure the sterile compounded drugs were sterile.

    Product
    TESTOSTERONE, Pellet, 90 mg, 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-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-0063-2016·2015-11-04

    FDA Recalls Chorionic Gonadotropin Syringes Due to Sterility Concerns

    The FDA is recalling 834 syringes of Chorionic Gonadotropin compounded by Moses Lake Professional Pharmacy because the agency cannot ensure the product is sterile.

    Product
    CHORIONIC GONADOTROPIN, Injectable Solution,175 UNITS/1.5mg per syringe with Methylcobalamin, 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-0150-2016·2015-11-04

    Moses Lake Pharmacy Recalls Six Trimix Syringes Due to Sterility Concerns

    JD & SN Inc. is recalling six syringes of Trimix injectable solution because the company cannot guarantee the product's sterility.

    Product
    TRIMIX, injectable Solution, 30MG/1MG/20MCG, 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-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 (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
  • SevereFDA (Drugs)·D-0143-2016·2015-11-04

    FDA Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    FDA is recalling Testosterone Cypionate for SubQ Injection from Moses Lake Professional Pharmacy due to lack of assurance of sterility.

    Product
    TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size: 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-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
  • HighFDA (Food)·F-0098-2016·2015-11-04

    Goya Mojo Criollo Marinade Recalled for Undeclared Peanut

    Goya Foods is recalling Mojo Criollo Marinade because an ingredient supplier reported that cumin used in the product may contain undeclared peanut protein.

    Product
    Goya Mojo Criollo Marinade for Chicken, Pork & Beef (a) 12 ounce (b) 24.5 oz and (c) 1 Gallon containers; Goya Foods, Inc., Secaucus, NJ 07096 USA Distributor. Product of Dominican Republic
    Category
    Food
    Distribution
    27 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
  • HighNHTSA·15V730000·2015-11-04

    Blue Bird School Bus Wheelchair Lift Recall for Bearing Defects

    Blue Bird is recalling certain school buses with Ricon wheelchair lifts where pivot holes may allow bearings to move, risking platform failure.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, MICRO BIRD, CONVENTIONAL
    Category
    Vehicle
    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
  • 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 (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-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 (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-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
  • HighNHTSA·15V731000·2015-11-04

    Blue Bird Transit Buses Recalled for Wheelchair Lift Bearing Defect

    Blue Bird is recalling 2007-2015 transit buses with Ricon wheelchair lifts where pivot holes may allow bearings to shift, risking platform failure.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, MICRO BIRD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2016·2015-11-04

    Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors

    Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.

    Product
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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 (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
  • 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-0105-2016·2015-11-04

    Kermit's Hot & Spicy Key Lime Barbecue Sauce Recalled for Undeclared Soy

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

    Product
    Kermit's Hot & Spicy Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501423 & 802468905312
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (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 (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

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