The Recall Desk

Archive

September 2015 recalls

1,186 recalls were announced in September 2015.

What the numbers show

Critical
119
Severe
574
High
366
Moderate
102
Low
25

Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 48% are Severe.

401–500 of 1186

  • SevereFDA (Drugs)·D-1443-2015·2015-09-23

    Compounded Ophthalmic Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Ascorbic Acid, Glutathione, and DMSO Ophthalmic Solution due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1731-2015·2015-09-23

    FDA Recalls Compounded Hydromorphone and Fentanyl Intrathecal Solution for Sterility Concerns

    The Compounding Pharmacy of America is recalling compounded intrathecal solutions due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1719-2015·2015-09-23

    Compounded Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling TRI-MIX injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1586-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 12.5 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1550-2015·2015-09-23

    Hydromorphone and Bupivacaine Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1810-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 1 0.14/0.08 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1703-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile morphine and bupivacaine solution because FDA inspections found violations that may affect sterility.

    Product
    Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1568-2015·2015-09-23

    Compounded Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling a compounded injectable due to GMP violations that may impact sterility.

    Product
    Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1704-2015·2015-09-23

    FDA Recalls Morphine, Clonidine, and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a sterile solution containing morphine, clonidine, and bupivacaine because an FDA inspection found GMP violations that may impact sterility.

    Product
    Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1643-2015·2015-09-23

    Testosterone Cypionate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1573-2015·2015-09-23

    Methylcobalamin Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Methylcobalamin 25,000 mcg/ml injections due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1680-2015·2015-09-23

    FDA Recalls Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone, Bupivacaine, and Clonidine intrathecal solution because FDA inspections found GMP violations affecting sterility.

    Product
    Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1698-2015·2015-09-23

    FDA Recalls MEGA-BURN IV Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling MEGA-BURN IV Injectable because FDA inspections found GMP violations that may affect sterility.

    Product
    MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1504-2015·2015-09-23

    FDA Recalls HCG and Hydroxocobalamin Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG and Hydroxocobalamin injections because an FDA inspection found violations that may affect sterility.

    Product
    HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V591000·2015-09-23

    Blue Bird Vision School Buses Recalled for Engine Stalling Risk

    Blue Bird is recalling 2016 Vision school buses because the Engine Control Module may short circuit, causing the engine to stall without warning.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1683-2015·2015-09-23

    Lipo-B MMC I Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipo-B MMC I Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1527-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,100 IU/ml Injection kits because FDA inspections found GMP violations that may impact sterility.

    Product
    HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1692-2015·2015-09-23

    Lipotropic B-12 Injection Recalled for Sterility Assurance Issues

    The Compounding Pharmacy of America is recalling Lipotropic B-12 II + Lidocaine Injection due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1651-2015·2015-09-23

    Testosterone Pellets Recalled for Potential Sterility Assurance Issues

    The Compounding Pharmacy of America is recalling Testosterone 50 mg Pellets because FDA inspections found GMP violations that may impact sterility.

    Product
    Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2015·2015-09-23

    Dexpanthenol Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Dexpanthenol 250 mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1715-2015·2015-09-23

    MYO-DEN Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling MYO-DEN Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 3,000 IU/ml injections because FDA inspections found GMP violations that may affect sterility.

    Product
    HCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2015·2015-09-23

    Copper Sulfate Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Copper Sulfate 2 mg/ml Injectable due to GMP violations that may impact sterility.

    Product
    Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1662-2015·2015-09-23

    Zinc Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Zinc 5 mg/ml Injectable due to GMP violations that may impact sterility.

    Product
    Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1533-2015·2015-09-23

    HCG Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling HCG 500 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.

    Product
    HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1491-2015·2015-09-23

    FDA Recalls Fentanyl and Clonidine Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Clonidine Intrathecal Solution because an FDA inspection found GMP violations that may have compromised the product's sterility.

    Product
    Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1771-2015·2015-09-23

    Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Tri-Mix (22.5/0.83/8.3) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1619-2015·2015-09-23

    Oxytocin Injection Recalled for Potential Sterility and Quality Issues

    The Compounding Pharmacy of America is recalling Oxytocin 100 units/ml Injection due to FDA-identified GMP violations that may impact sterility and product quality.

    Product
    Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1663-2015·2015-09-23

    Zinc Chloride Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Zinc Chloride 25mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1762-2015·2015-09-23

    Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix injectable products because an FDA inspection found GMP violations that may affect sterility.

    Product
    Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1746-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 25 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1432-2015·2015-09-23

    Compounded 5-Methyl Tetrahydrofolate Injectable Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling 5-Methyl Tetrahydrofolate injectable vials due to GMP violations that may impact sterility.

    Product
    5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1736-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 30 mg/ml Solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1583-2015·2015-09-23

    Mitomycin Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Mitomycin Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1691-2015·2015-09-23

    Lipotropic B-12 Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipotropic B-12 Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1478-2015·2015-09-23

    Estradiol Valerate Injectable Vials Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Valerate 20 mg/ml injectable vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2015·2015-09-23

    Collagenase Recall Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Collagenase 250 units/ml vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1465-2015·2015-09-23

    FDA Recalls Estradiol Pellets Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Estradiol 100 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.

    Product
    Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1450-2015·2015-09-23

    Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.

    Product
    Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 20 mg sterile pellets nationwide because FDA inspections identified GMP violations that may impact sterility.

    Product
    Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1601-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1735-2015·2015-09-23

    FDA Recalls MEGA-BURN Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling MEGA-BURN injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1629-2015·2015-09-23

    Sermorelin Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sermorelin 1000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1452-2015·2015-09-23

    Cholecalciferol Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cholecalciferol 500,000 IU/ml Injectable due to GMP violations that may impact sterility.

    Product
    Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1572-2015·2015-09-23

    Methylcobalamin Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Methylcobalamin 5,000 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1584-2015·2015-09-23

    Mitomycin Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mitomycin Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1801-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9E injectable products because an FDA inspection found violations that may affect sterility.

    Product
    Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1686-2015·2015-09-23

    Compounded Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling LIPO-EXTREME Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1799-2015·2015-09-23

    Tri-Mix ST9A Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9A Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1628-2015·2015-09-23

    Selenium Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Selenium 200 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1620-2015·2015-09-23

    Compounded Alprostadil Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling PGE 150 (Alprostadil) due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1530-2015·2015-09-23

    HCG Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 4,000 IU/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1654-2015·2015-09-23

    Testosterone Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 72.5 mg Pellets due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1471-2015·2015-09-23

    Estradiol Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Estradiol 25 mg sterile pellets nationwide due to GMP violations that may impact sterility.

    Product
    Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1520-2015·2015-09-23

    FDA Recalls HCG Injection Vials Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG 10,000 IU/ml Injection vials because FDA inspections found GMP violations that may affect sterility.

    Product
    HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1587-2015·2015-09-23

    Morphine Solution Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Morphine 15 mg/ml Solution due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Morphine 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1549-2015·2015-09-23

    Hydromorphone Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 30 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1561-2015·2015-09-23

    L-Arginine Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling L-Arginine 100 mg/ml Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1606-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Morphine 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1515-2015·2015-09-23

    HCG Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits due to FDA inspection findings of GMP violations that impact sterility.

    Product
    HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1788-2015·2015-09-23

    Tri-Mix AT-1 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix AT-1 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1761-2015·2015-09-23

    Tri-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1626-2015·2015-09-23

    Progesterone Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Progesterone 100 mg/ml Injection due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1488-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1644-2015·2015-09-23

    FDA Recalls Testosterone Cypionate and Anastrazole Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V593000·2015-09-23

    Yamaha Recalls 2015 YZF-R3 Motorcycles Due to Cracking Triple Clamp

    Yamaha is recalling 2015 YZF-R3 motorcycles because the upper triple clamp may crack, potentially causing loss of steering control and increasing crash risk.

    Product
    YAMAHA — YAMAHA redundant YZF-R3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1510-2015·2015-09-23

    HCG Injection Recall Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml Injection kits nationwide due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1459-2015·2015-09-23

    Cyanocobalamin and B-Complex Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1564-2015·2015-09-23

    Magnesium Chloride Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Magnesium Chloride 200 mg/ml Injection due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1600-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution because FDA inspections found violations that may affect sterility.

    Product
    Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2770-2015·2015-09-23

    Lumenis VersaCut+ Tissue Morcellator Hand Pieces Recalled for Unpredictable Operation

    Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.

    Product
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and…
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1440-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Alprostadil 50 mcg/ml Injection because an FDA inspection found GMP violations that may impact sterility.

    Product
    Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1542-2015·2015-09-23

    FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 10 mg/ml Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1796-2015·2015-09-23

    Tri-Mix ST4 Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST4 Injectable due to GMP violations that may impact sterility. The recall covers lots distributed nationwide from November 2014 to May 2015.

    Product
    Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1790-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix MEDIUM Injectable nationwide due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1511-2015·2015-09-23

    Compounded HCG and Methylcobalamin Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3235-2015·2015-09-23

    Tipico Dry Grated Romano Recalled for Listeria Monocytogenes

    Tipico Products Company is recalling 2,000 pounds of Dry Grated Romano in Iowa due to a health risk from Listeria monocytogenes.

    Product
    Dry Grated Romano, Tipico Item #1-00111000, Net Wt. 50 lbs.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1508-2015·2015-09-23

    Compounded HCG and B-12 Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml + MIC B-12 Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2769-2015·2015-09-23

    Applied Medical Resources Recalls Voyant Open Fusion Devices

    Applied Medical Resources Corp is recalling Voyant Open Fusion Devices due to a potential risk of improper tissue characterization, which may result in nonoptimal power delivery.

    Product
    Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1647-2015·2015-09-23

    Testosterone Enanthate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2015·2015-09-23

    Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues

    Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.

    Product
    XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2777-2015·2015-09-23

    Medtronic CryoConsole Recalled Due to USB Component Issue

    Medtronic is recalling 103 CryoConsole units because a USB memory component issue can result in extended procedure time during cardiac ablation.

    Product
    Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3231-2015·2015-09-23

    Valley View Orchard Pies Recalls Blueberry Crisp for Undeclared Soy

    Valley View Orchard Pies Inc. is recalling Blueberry Crisp products due to undeclared soy lecithin. The products were distributed in Maine, New Hampshire, and Massachusetts.

    Product
    Valley View Orchard Pies, Blueberry Crisp
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2767-2015·2015-09-23

    Nico Myriad Console Recalled for Potential Cable Malfunction

    Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.

    Product
    NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2761-2015·2015-09-23

    Medivators Recalls Hemocor HPH700 Hemoconcentrators Due to Low Ultrafiltration Performance

    Medivators, Inc. is recalling 840 Hemocor HPH700 Hemoconcentrators because they may exhibit low ultrafiltration performance below product specifications.

    Product
    Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-1688-2015·2015-09-23

    Compounding Pharmacy Recalls LIPO-VITE Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling LIPO-VITE Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2015·2015-09-23

    Sony Medical Monitors Recalled for Failure to Power On or Display Image

    Sony Medical Systems is recalling 4,952 medical monitors that may fail to turn on or lose image during clinical use.

    Product
    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-3233-2015·2015-09-23

    Valley View Orchard Apple Crisp Tray Recalled for Undeclared Soy Lecithin

    Valley View Orchard Pies Inc. is recalling Apple Crisp Tray products due to undeclared soy lecithin. The products were distributed in Maine, New Hampshire, and Massachusetts.

    Product
    Valley View Orchard Pies, Apple Crisp Tray
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1454-2015·2015-09-23

    Clotrimazole Otic Suspension Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3226-2015·2015-09-23

    KellBran Caramel Popcorn Recalled for Undeclared Milk Allergen

    KellBran Candies is recalling 8 oz. bags of creamy rich caramel popcorn because the product may contain undeclared milk, a major food allergen.

    Product
    KellBran" CANDIES, INC. creamy rich caramel popcorn Net Wt. 8 oz. (226.64 Grams) ALLERGY INFO: Manufactured in a facility that processes peanuts, nuts, soy and milk. UPC 0 96637 50153 9 kellbrancandies.com KellBran Candies, Inc. Akron, Ohio 44312
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-3230-2015·2015-09-23

    Valley View Orchard Apple Crisp Pie Recalled for Undeclared Soy

    Valley View Orchard Pies Inc. is recalling Apple Crisp Pies due to undeclared soy lecithin. The product was distributed in Maine, New Hampshire, and Massachusetts.

    Product
    Valley View Orchard Pies, Apple Crisp Pie
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-1616-2015·2015-09-23

    Nandrolone Decanoate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2015·2015-09-23

    Bayer Medrad Mark 7 Arterion Injection System Software Recall

    Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.

    Product
    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2772-2015·2015-09-23

    Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects

    Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.

    Product
    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1742-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting sterility.

    Product
    Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1696-2015·2015-09-23

    Compounded MEGA-BURN Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling MEGA-BURN Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3228-2015·2015-09-23

    Valley View Orchard Raspberry Rhubarb Pies Recalled for Undeclared Soy

    Valley View Orchard Pies Inc. is recalling Raspberry Rhubarb Pies due to undeclared soy lecithin. The product was distributed in Maine, New Hampshire, and Massachusetts.

    Product
    Valley View Orchard Pies, Raspberry Rhubarb
    Category
    Food
    Distribution
    3 states

Looking for a different month? Back to 2015.