The Recall Desk

Archive

July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical
82
Severe
382
High
263
Moderate
177
Low
17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 41% are Severe.

401–500 of 921

  • SevereFDA (Drugs)·D-1330-2016·2016-07-20

    Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml due to a lack of assurance of sterility.

    Product
    Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0939-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1267-2016·2016-07-20

    Pharmakon Recalls Midazolam Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 40 vials of compounded Midazolam (PF) 5mg/ml 25 mL BD syringes due to a lack of assurance of sterility.

    Product
    Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1285-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Cadd Cassettes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1266-2016·2016-07-20

    Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 400 syringes of compounded Epinephrine due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.

    Product
    Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1171-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex Without B12 vials because the FDA could not ensure the product was sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.

    Product
    B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1291-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because the company cannot ensure the products are sterile.

    Product
    Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1248-2016·2016-07-20

    Medaus Recalls TMG 100 mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling TMG 100 mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1194-2016·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of L-Carnitine 100mg/mL vials because the company cannot ensure the product is sterile.

    Product
    L-CARNITINE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1180-2016·2016-07-20

    Medaus Recalls DMPS 50mg/mL Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1230-2016·2016-07-20

    Medaus Recalls Nandrolone Decanoate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Nandrolone Decanoate 200mg/mL vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1205-2016·2016-07-20

    Medaus Recalls Lipo-Boost Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Lipo-Boost vials because the company cannot guarantee the product's sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1318-2016·2016-07-20

    Pharmakon Recalls Vancomycin HCL 1.25 GM Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 216 units of Vancomycin HCL 1.25 GM in 5% Dextrose bags due to a lack of assurance of sterility.

    Product
    Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1197-2016·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling L-Carnitine 500mg/mL vials because the company cannot assure the product's sterility. The recall covers products distributed in the U.S., Japan, and New Zealand.

    Product
    L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1313-2016·2016-07-20

    Pharmakon Recalls Atropine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 400 units of Atropine Sulfate syringes because the company cannot ensure the products are sterile.

    Product
    Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1633-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Veggie Burgers for Listeria Risk

    Dr. Praeger's is voluntarily recalling Aldi California/Black Bean Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Aldi California/Black Bean Veggie Burgers, Net 15.0 lbs, 24 x 10 oz (284g)/box, Sale By: May -09-2018
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1191-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.

    Product
    HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1299-2016·2016-07-20

    Pharmakon Recalls Oxytocin Lactated Ringers Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin in Lactated Ringers due to a lack of assurance of sterility.

    Product
    Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1173-2016·2016-07-20

    Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex 50 vials because the company cannot ensure the product is sterile.

    Product
    B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1195-2106·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling L-Carnitine 50mg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.

    Product
    L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1210-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Lipo-Injection vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1273-2016·2016-07-20

    Pharmakon Recalls Promethazine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 40 units of compounded Promethazine injection due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.

    Product
    Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1348-2016·2016-07-20

    Murray International Recalls Unapproved Sciatica Pills Marketed as Supplements

    Murray International Trading Co. is recalling 144 bottles of Sciatica Pills because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1237-2016·2016-07-20

    Medaus Recalls Riboflamin Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling specific lots of Riboflavin 10mg/mL vials because the company cannot ensure the product is sterile.

    Product
    RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1172-2016·2016-07-20

    Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex 50 in NaCl 0.9% vials because the company cannot assure the sterility of the product.

    Product
    B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1315-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 215 bags of Morphine Sulfate in Dextrose due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1178-2016·2016-07-20

    Medaus Recalls Dexpantenol Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile.

    Product
    DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1293-2016·2016-07-20

    Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1198-2016·2016-07-20

    Medaus Recalls L-Glutathione Vials Due to Sterility Concerns

    Medaus, Inc. is recalling L-Glutathione 100mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1643-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Veggie Burgers Due to Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling specific frozen veggie burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's Tex Mex Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: Jan -4-2018, UPC (01) 6 0080868 00048 , Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1645-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Veggie Burger Sliders Due to Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burger Sliders because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burger Sliders (Vegan), 1.5 oz., 10 lbs. (4.54 kg), Best if used by: May-17-2018, UPC (01) 0 0080868 01015, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1212-2016·2016-07-20

    Medaus Recalls Manganese Chloride Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Manganese Chloride 0.1mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1676-2016·2016-07-20

    Kroger Sunflower Kernels Recalled for Listeria Contamination Risk

    The Kroger Co is recalling Roasted & Salted Sunflower Kernels because the supplier notified them of a potential Listeria monocytogenes contamination.

    Product
    Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4
    Category
    Food
    Distribution
    28 states
  • SevereFDA (Drugs)·D-1174-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials because the company cannot ensure the product is sterile.

    Product
    B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1271-2016·2016-07-20

    Pharmakon Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Potassium Chloride IV bags because they may not be sterile. The recall covers products distributed nationwide and to specific VA/DOD facilities.

    Product
    Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1169-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling B-Complex (Lieberman) in NaCl 0.9% (PF) 2 mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1646-2016·2016-07-20

    Dr. Praeger's California Veggie Burgers Recalled for Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling California Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burgers, 26 x 10 oz./box, Best if used by: May-18-2018, UPC 0 80868 00010, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1253-2016·2016-07-20

    Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is sterile.

    Product
    ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1637-2016·2016-07-20

    Dr. Praeger's California Veggie Burgers Recalled for Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling California Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burgers, 12 x 11 oz. (312g)/box, Best if used by: May-16-2018, UPC 0 0080868 000010 7, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1648-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Veggie Burgers Due to Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 01010 6, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1295-2016·2016-07-20

    Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin 30 Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1263-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 200 units of Fentanyl Citrate injection due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1204-2016·2016-07-20

    Medaus Recalls Lipo B Cyano Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo B Cyano 1mg/mL vials because the company cannot ensure the product is sterile.

    Product
    LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1244-2016·2016-07-20

    Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific vials of Testosterone Cypionate 25 mg/mL due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.

    Product
    TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1202-2016·2016-07-20

    Medaus Recalls Lipo #4 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Lipo #4 vials because the FDA cannot assure the product is sterile. The recall affects vials distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1649-2016·2016-07-20

    Dr. Praeger's Recalls Frozen Veggie Burgers for Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's California Veggie Burger (Vegan), 4 oz., 10 lbs (4.54 kg), Best if used by: May-16-2018, UPC (01)0 0080868 97010 3, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1310-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1233-2016·2016-07-20

    Medaus Recalls Proline 100mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Proline 100mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1317-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 45 units of Morphine Sulfate IV bags due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1635-2016·2016-07-20

    Dr. Praeger's Recalls Quinoa Cowboy Veggie Burgers for Listeria Risk

    Dr. Praeger's is voluntarily recalling Trader Joe's Quinoa Cowboy Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Trader Joe's Quinoa Cowboy Veggie Burger, 26 x 12 oz. (340g)/box, Best if used by: May-12-2018, UPC 0053 2761, Dist. & Sold Exclusively By: Trader Joe's, Monrovia CA 91016
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1652-2016·2016-07-20

    Dr. Praeger's Recalls Black Bean Veggie Burgers Due to Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling specific lots of Black Bean Veggie Burgers because they may be contaminated with Listeria monocytogenes.

    Product
    Dr. Praeger's Black Bean Veggie Burger, 12 x 10 oz. (283 g)/box, Best if used by: May-12-2018, UPC 0 80868 06019 4, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1256-2016·2016-07-20

    Pharmakon Recalls Phenylephrine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Phenylephrine 40 mcg/mL injection syringes due to a lack of assurance of sterility.

    Product
    Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1319-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1303-2016·2016-07-20

    Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 70 bags of Norepinephrine Bitartrate 8mg in 5% Dextrose due to a lack of assurance of sterility.

    Product
    Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1222-2016·2016-07-20

    Medaus Recalls B-Complex Premix Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of M.I.C B-Complex Premix vials because the company cannot ensure the product is sterile.

    Product
    M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1284-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Cadd Cassettes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.

    Product
    Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1216-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Methyl B12 10mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1238-2016·2016-07-20

    Medaus Recalls Selenium Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling specific lots of Selenium 200mcg/mL vials because the company cannot ensure the product is sterile.

    Product
    SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1211-216·2016-07-20

    Medaus Recalls Magnesium Chloride Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Magnesium Chloride 200mg/mL vials because the company cannot assure the sterility of the product.

    Product
    MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1301-2016·2016-07-20

    Pharmakon Recalls Epinephrine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Epinephrine HCI syringes because the company cannot ensure the products are sterile.

    Product
    Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1217-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific vials of Methyl B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.

    Product
    METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1209-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot guarantee the product is sterile.

    Product
    LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1305-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 560 vials of Hydromorphone HCl 0.4mg/mL in 30 mL syringes due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1312-2016·2016-07-20

    Pharmakon Recalls Hydromorphone IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags due to a lack of assurance of sterility.

    Product
    Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1328-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 340 units of Morphine Sulfate syringes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD locations.

    Product
    Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1221-2016·2016-07-20

    Medaus Recalls M.I.C./B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C./B-Complex (PF) vials because the company cannot assure the sterility of the product. The recall affects 3,000 mL in vials distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C./B-COMPLEX (PF) B1-50MG;B2-5-PO4-5MG;B3-50MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-5MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1283-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Cadd Cassettes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1290-2016·2016-07-20

    Pharmakon Recalls Provocholine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 142 units of Provocholine pre-diluted syringes nationwide due to a lack of assurance of sterility.

    Product
    Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.

    Product
    Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of internal sutures, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2016·2016-07-20

    Novarad NovaPACS Diagnostic Viewer Recall for Image Orientation Flipping

    Novarad Corporation is recalling NovaPACS Diagnostic Viewer software versions 7.4, 7.5, 7.6, and 8.0 because images may flip during streaming, potentially displaying incorrect orientation markers.

    Product
    NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2178-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2016·2016-07-20

    Sorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.

    Product
    AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2016·2016-07-20

    Stryker Recalls 5.0mm Round Fluted Burs Due to Corrosion Risk

    Stryker Instruments is voluntarily recalling specific lots of 5.0mm Round Fluted Burs because tarnishing or corrosion may cause inflammation requiring surgery.

    Product
    5.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2200-2016·2016-07-20

    Medtronic Temporary Pacing Lead System Recalled for Design Non-Compliance

    Medtronic is recalling Temporary Pacing Lead Systems because they do not meet design standards preventing connection to hazardous voltage.

    Product
    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is dispos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may have reduced their stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1590-2016·2016-07-20

    Silva International Recalls Dehydrated Chipotle Powder for Undeclared Gluten

    Silva International is recalling 2,908 lbs of dehydrated chipotle powder because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.

    Product
    Dehydrated chipotle powder from Silva International packaged in a 50 lb. poly-lined cardboard box.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1667-2016·2016-07-20

    Silva International Recalls Zesty Nacho Spice Blend for Undeclared Gluten

    Silva International is recalling 10,000 lbs of Zesty Nacho Spice Blend because samples tested positive for gluten, possibly from wheat, which was not disclosed on the label.

    Product
    Zesty Nacho Spice Blend (containing dehydrated chipotle powder) from Silva International packaged in a 50 lb. poly-lined cardboard box.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1680-2016·2016-07-20

    Magic Seasoning Blends Recalls Outback Steakhouse Batter for Peanut Allergen

    Magic Seasoning Blends is recalling specific lots of Outback Steakhouse OSI Mama's Batter due to potential peanut protein contamination.

    Product
    OUTBACK STEAKHOUSE OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL 33609
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing defects may have damaged internal sutures, leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1214-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Methyl B12 1000mcg/mL vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

    Product
    METHYL B12 1000MCG/ML W/PRES (BENZALKONIUM 0.01% IN NACL 0.9%, In a) 2ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·16E063000·2016-07-20

    Eaton Recalls Spool Valve Motors Due to Potential Shaft Breakage

    Eaton is recalling specific Spool Valve Motors because the motor shaft may break, potentially causing unexpected movement of hydraulic booms or winches and increasing injury risk.

    Product
    EQUIPMENT:MECHANICAL:WINCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V544000·2016-07-20

    Ferrara Recalls 2011-2016 Emergency Vehicles for Touchscreen Defect

    Ferrara is recalling 2011-2016 emergency vehicles because touchscreen false activations may turn accessories on or off, increasing crash risk.

    Product
    FERRARA — FERRARA INFERNO, INTRUDER, IGNITER, CINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1682-2016·2016-07-20

    Outback Steakhouse Breading Mix Recalled for Potential Peanut Presence

    Magic Seasoning Blends is recalling Outback Steakhouse Complete Breading Mix due to potential peanut protein in the flour used.

    Product
    OUTBACK STEAKHOUSE COMPLETE BREADING MIX, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1681-2016·2016-07-20

    Outback Steakhause Breader Recalled for Potential Peanut Protein

    Magic Seasoning Blends is recalling Outback Steakhause breader due to potential peanut protein in the flour used.

    Product
    OUTBACK STEAKHOUSE CRAWFISH/CHICKEN/CALAMARI BREADER, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1228-2016·2016-07-20

    Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL vials because the company cannot ensure the product is sterile.

    Product
    NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1219-2016·2016-07-20

    Medaus Recalls Methyl B12 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Methyl B12 10mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2016·2016-07-20

    Stryker Recalls Specific Lots of Round Fluted Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.

    Product
    6.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2180-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035452040 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2016·2016-07-20

    Varian AlignRT Plus Optical Surface Monitoring System Recall for Parameter Errors

    Varian Medical Systems is recalling AlignRT Plus systems because unintended changes to couch rotation parameters can occur during patient set-up.

    Product
    Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2016·2016-07-20

    Stryker Target Nano Coils Recalled for Manufacturing Defect

    Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.

    Product
    Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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