The Recall Desk

Archive

July 2016 recalls

921 recalls were announced in July 2016.

What the numbers show

Critical
82
Severe
408
High
239
Moderate
175
Low
17

Of the 921 recalls this month scored against our rubric, 9% are Critical, 44% are Severe.

301–400 of 921

  • SevereFDA (Drugs)·D-1278-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 4,500 units of Hydromorphone 1mg/mL syringes due to a lack of assurance of sterility.

    Product
    HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78
    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 (Drugs)·D-1206-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling Lipo-Injection vials containing methyl B12 and other vitamins due to a lack of assurance of sterility.

    Product
    LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-1MG, 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-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-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-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-1314-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 75 bags of Fentanyl Citrate injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1260-2016·2016-07-20

    Pharmakon Recalls Succinylcholine Chloride Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 650 syringes of Succinylcholine Chloride 20 mg/mL injection due to a lack of assurance of sterility.

    Product
    Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0104-70
    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-1297-2016·2016-07-20

    Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 72 units of compounded Oxytocin 10 Units in Lactated Ringers due to a lack of assurance of sterility.

    Product
    Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
    Category
    Drug
    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-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 (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-1249-2016·2016-07-20

    Medaus Recalls Tryptophan Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Tryptophan 10mg/mL vials because the company cannot ensure the product is sterile. The recall affects 10mL and 50mL vials distributed in the U.S., Japan, and New Zealand.

    Product
    TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY
    Category
    Drug
    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-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-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 (Devices)·Z-2140-2016·2016-07-20

    Hospira PCA 3 Infusion Pump Recall for Occlusion Detection Failure

    Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.

    Product
    The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3…
    Category
    Medical Device
    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-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-1226-2016·2016-07-20

    Medaus Recalls Minoxidil Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling specific lots of Minoxidil 0.5% vials because the company cannot ensure the product is sterile.

    Product
    MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1281-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.

    Product
    Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1307-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Morphine Sulfate syringes because the company cannot guarantee the products are sterile.

    Product
    Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1277-2016·2016-07-20

    Pharmakon Recalls Phenylephrine HCI Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Phenylephrine HCI 40mg/250 mL bags because the company cannot ensure the products are sterile.

    Product
    Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1246-2016·2016-07-20

    Medaus Recalls Thiamine Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Thiamine 100 mg/mL vials because the company cannot assure the sterility of the product. The recall covers lots distributed in the U.S., Japan, and New Zealand.

    Product
    THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY
    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-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-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-1231-2016·2016-07-20

    Medaus Recalls Niacinamide Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Niacinamide 100 mg/mL vials because the company cannot guarantee the product's sterility.

    Product
    NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1336-2016·2016-07-20

    Pharmakon Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL syringes because the company cannot guarantee the products are sterile.

    Product
    Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1296-2016·2016-07-20

    Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,809 units of compounded Oxytocin infusion bags nationwide due to a lack of assurance of sterility.

    Product
    Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0740-04
    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-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 (Devices)·Z-2139-2016·2016-07-20

    Hospira Recalls LifeCare PCA Plus II Infusion Pumps Due to Occlusion Detection Failure

    Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.

    Product
    The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units…
    Category
    Medical Device
    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-1262-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 12 units of Hydromorphone HCl injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride, 100 mL Cadd Cassette (grey), Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0114-48
    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-1275-2016·2016-07-20

    Pharmakon Recalls Promethazine IV Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 725 units of compounded Promethazine IV bags due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41
    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 (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-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-1333-2016·2016-07-20

    Pharmakon Recalls Rocuronium Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,925 vials of Rocuronium 10 mg/mL syringes because the company cannot guarantee the product is sterile.

    Product
    Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0955-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1359-2016·2016-07-20

    Hospira Recalls Diazepam Injection Due to Crystallized Active Ingredient

    Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL because the product contains particulate identified as crystallized active ingredient.

    Product
    DIAZEPAM — DIAZEPAM (DIAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1630-2016·2016-07-20

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

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

    Product
    Dr. Praeger's Purely Sensible Foods Jumbo California Veggie Burger (Vegan), 5.5 oz., 10 lbs (4.54.kg), Best if used by: May 17, 2018, UPC (01) 00080868 01011, Dr. Praegers Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1242-2016·2016-07-20

    Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

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

    Product
    TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1304-2016·2016-07-20

    Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 670 vials of compounded Hydromorphone HCl 0.4mg/ml due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.

    Product
    HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1642-2016·2016-07-20

    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 Bombay Veggie Burgers, 6 x 10 oz. (283g)/box, Best if used by: May-12-2018, UPC (01) 6 0080868 000050 5, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    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-1188-2016·2016-07-20

    Medaus Recalls Hyaluronidase Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Hyaluronidase 500U/ML vials because the company cannot assure the sterility of the product. The recall affects lots distributed in the U.S., Japan, and New Zealand.

    Product
    HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1276-2016·2016-07-20

    Pharmakon Recalls Promethazine Compounded Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 485 units of compounded Promethazine 25 mg in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.

    Product
    Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41
    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-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-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-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-1279-2016·2016-07-20

    Pharmakon Recalls Cefazolin Sodium Chloride Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 100 mL 0.9% Sodium Chloride bags because the company cannot guarantee the products are sterile.

    Product
    Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48
    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-1308-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Compounded Syringes for Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 260 syringes of compounded fentanyl and bupivacaine due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77
    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-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-1294-2016·2016-07-20

    Pharmakon Recalls Ketamine Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 600 vials of compounded Ketamine 100mg/mL due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.

    Product
    Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1176-2016·2016-07-20

    Medaus Recalls Calcium Sodium EDTA Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Calcium Sodium EDTA 300mg/mL vials because the agency cannot assure the product's sterility.

    Product
    CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    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-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-1332-2016·2016-07-20

    Pharmakon Recalls Lidocaine Syringes Due to Sterility Assurance Concerns

    Pharmakon Pharmaceuticals is recalling 50 vials of Lidocaine 2% syringes because the company cannot ensure the products are sterile.

    Product
    Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
    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 (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-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-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-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 (Food)·F-1644-2016·2016-07-20

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

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

    Product
    Dr. Praeger's California Veggie Balls (Vegan), 1 oz., 10 lbs. (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 01310, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    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-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-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-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-1322-2016·2016-07-20

    Pharmakon Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 2,175 units of Succinylcholine Chloride 20 mg/mL syringes due to a lack of assurance of sterility.

    Product
    Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1298-2016·2016-07-20

    Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 468 units of compounded Oxytocin 30 Units in Lactated Ringers due to a lack of assurance of sterility.

    Product
    Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03
    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-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-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-1320-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 20 bags of compounded Fentanyl Citrate and Ropivacaine HCI due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48
    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 (Food)·F-1651-2016·2016-07-20

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

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

    Product
    Dr. Praeger's GF California Veggie Burger, 4 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 01060, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1177-2016·2016-07-20

    Medaus Recalls Cesium Chloride Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Cesium Chloride 600mg/mL vials because the company cannot assure the sterility of the product.

    Product
    CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    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 (Devices)·Z-2141-2016·2016-07-20

    Hospira Recalls LifeCare PCA Infusion Systems Due to Occlusion Detection Failure

    Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.

    Product
    LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1641-2016·2016-07-20

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

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

    Product
    Dr. Praeger's Black Bean Slider, 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06615, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    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-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
  • SevereFDA (Drugs)·D-1239-2016·2016-07-20

    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 (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML 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 (Food)·F-1650-2016·2016-07-20

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

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

    Product
    Dr. Praeger's Chipotle Black Bean Burger, 4.25 oz., 10 lbs (4.54 kg), Best if used by: May-12-2018, UPC (01) 0 0080868 06621 9, Dr. Praeger's Sensible Foods, Elmwood Park, NJ 07407
    Category
    Food
    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-1306-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 50 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02
    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-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-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-1223-2016·2016-07-20

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

    Medaus, Inc. is recalling M.I.C B-Complex vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.

    Product
    M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG;B6-5MG; CYANO B12 100MCG; CHOLINE CHL-50MG; INOSITOL-25MG;METHIONINE 12.5MG/ML, 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

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