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.

301–400 of 921

  • 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 (Drugs)·D-1232-2016·2016-07-20

    Medaus Recalls Procaine 2% Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Procaine 2% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    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 (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 (Drugs)·D-1326-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 120 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1339-2016·2016-07-20

    Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,200 units of Rocuronium 10mg/ml syringes because the company cannot ensure the product is sterile.

    Product
    Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1338-2016·2016-07-20

    Pharmakon Recalls Midazolam HCI Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.

    Product
    Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1343-2016·2016-07-20

    Pharmakon Recalls Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.

    Product
    Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1316-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 300 bags of Morphine Sulfate 1mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41
    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-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-1334-2016·2016-07-20

    Pharmakon Recalls Ondansetron Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 2,300 units of compounded Ondansetron 2mg/mL syringes because the company cannot ensure the product is sterile.

    Product
    Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0957-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1287-2016·2016-07-20

    Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 200 units of compounded Ketamine 50mg/mL syringes due to a lack of assurance of sterility.

    Product
    Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78
    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-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-1258-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Ropivacaine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 150 bags of compounded Fentanyl Citrate and Ropivacaine HCI injection due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01
    Category
    Drug
    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-1247-2016·2016-07-20

    Medaus Recalls Thiamine Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling specific lots of Thiamine 100 mg/mL vials because the company cannot guarantee the product is sterile.

    Product
    THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
    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-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 (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 (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 (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-1252-2016·2016-07-20

    Medaus Recalls Arginine Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure the product is sterile.

    Product
    ARGININE 100MG/ML (PF), 10ML 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 (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-1259-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 50 mcg/ml injections due to a lack of assurance of sterility. The recall affects 4,050 syringes distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0100-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1182-2016·2016-07-20

    Medaus Recalls EDTA Disodium Vials Due to Sterility Concerns

    Medaus, Inc. is recalling EDTA Disodium 15% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY
    Category
    Drug
    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 (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 (Drugs)·D-1181-2016·2016-07-20

    Medaus Recalls DMSO 99.9 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling DMSO 99.9 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
    DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1323-2016·2016-07-20

    Pharmakon Recalls Ketamine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 175 units of compounded Ketamine 20 mg/mL due to a lack of assurance of sterility.

    Product
    Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41
    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
  • 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-1272-2016·2016-07-20

    Pharmakon Recalls Norepinephrine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 24 bags of compounded Norepinephrine 16 mg in 0.9% sodium chloride due to a lack of assurance of sterility.

    Product
    Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02
    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-1337-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL because the company cannot ensure the products are sterile.

    Product
    Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70
    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-1190-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

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

    Product
    HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    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-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-1179-2016·2016-07-20

    Medaus Recalls Dexpantenol Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling Dexpantenol 250mg/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
    DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1220-2016·2016-07-20

    Medaus Recalls M.I.C. 25/50/50 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling M.I.C. 25/50/50 (PF) vials because the company cannot ensure the product is sterile. The recall covers multiple lots distributed in the U.S., Japan, and New Zealand.

    Product
    M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 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-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-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-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-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-1207-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

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

    Product
    LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1274-2016·2016-07-20

    Pharmakon Recalls Methohexital Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL because the company cannot ensure the product is sterile.

    Product
    Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1261-2016·2016-07-20

    Pharmakon Recalls Ceftriaxone Injections Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,575 units of compounded Ceftriaxone 1GM injections due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1170-2016·2016-07-20

    Medaus Recalls B-Complex Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex Without B12 vials because the company cannot assure the sterility of the product.

    Product
    B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2016·2016-07-20

    FDA Recalls Crocodile Bile Pills Marketed as Unapproved Asthma Drug

    Murray International Trading Co. is recalling Crocodile Bile Pills for Asthma because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

    Product
    CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1309-2016·2016-07-20

    Pharmakon Recalls Diltiazem HCI Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Diltiazem HCI 250 mg in 5% Dextrose due to a lack of assurance of sterility.

    Product
    Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02
    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-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-1186-2106·2016-07-20

    Medaus Recalls GABA 50mg/mL Vials Due to Sterility Concerns

    Medaus, Inc. is recalling GABA 50mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    GABA 50MG/ML (PF), 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1203-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Lipo-Injection vials containing lidocaine and vitamins due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.

    Product
    LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/ML, 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1340-2016·2016-07-20

    Pharmakon Recalls Vecuronium Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1251-2016·2016-07-20

    Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

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

    Product
    ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
    Category
    Drug
    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-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-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-1240-2016·2016-07-20

    Medaus Recalls Taurine Vials Due to Lack of Sterility Assurance

    Medaus, Inc. is recalling Taurine 50 mg/mL vials because the company cannot assure the product is sterile.

    Product
    TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1311-2016·2016-07-20

    Pharmakon Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Norepinephrine Bitartrate 4 mg in 5% Dextrose bags because the company cannot ensure the products are sterile.

    Product
    Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02
    Category
    Drug
    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-1208-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the FDA determined there is a lack of assurance of sterility.

    Product
    LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS
    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-1327-2016·2016-07-20

    Pharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 800 syringes of Phenylephrine HCI 100mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1286-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.

    Product
    Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2016·2016-07-20

    Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns

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

    Product
    HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML 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-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-1347-2016·2016-07-20

    FUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA

    Murray International Trading Co. is recalling FUCONPO Capsules because they are marketed as dietary supplements but bear drug claims, making them unapproved drugs.

    Product
    FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2016·2016-07-20

    Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns

    Medaus, Inc. is recalling B-Complex #3 vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML 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-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-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-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 (Drugs)·D-1229-2016·2016-07-20

    Medaus Recalls Sodium Ascorbate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vials, MEDAUS PHARMACY
    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 (Food)·F-1636-2016·2016-07-20

    Dr. Praeger's Recalls Ungar's Veggie Balls Due to Listeria Risk

    Dr. Praeger's Sensible Foods is voluntarily recalling Ungar's Veggie Balls (Vegan) because they may be contaminated with Listeria monocytogenes.

    Product
    Ungar's Veggie Balls (Vegan), 1 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC 0 0080868 81310 3, Ungar's Food Products, Elmwood Park, NJ 07407
    Category
    Food
    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-1341-2016·2016-07-20

    Pharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1254-2016·2016-07-20

    Medaus Recalls Hydrochloric Acid Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of HCL 2MG/ML (PF) 5ML Vials because the company cannot ensure the product is sterile.

    Product
    HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1634-2016·2016-07-20

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

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

    Product
    Aldi Kale Burger, Net 18.75 lbs, 30 x 10 oz (284 grams), Sell By: May -17-2018
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1288-2016·2016-07-20

    Pharmakon Recalls Bupivacaine HCI Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 40 units of Bupivacaine HCI 0.125% syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1325-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 90 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    HYDROmorphone HCI 1mg/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 45183-0932-68
    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-1302-2016·2016-07-20

    Pharmakon Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.

    Product
    Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
    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-1265-2016·2016-07-20

    Pharmakon Recalls Epinephrine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 280 vials of compounded Epinephrine injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72
    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-1638-2016·2016-07-20

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

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

    Product
    Dr. Praeger's Black Bean Burger (Vegetarian), 3.3 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06617, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2016·2016-07-20

    Medaus Recalls B-Complex and Lidocaine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials because the company cannot guarantee the product is sterile.

    Product
    B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 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-1245-2016·2016-07-20

    Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1184-2016·2016-07-20

    Medaus Recalls Folic Acid Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.

    Product
    FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide

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