The Recall Desk

Archive

September 2015 recalls

1,186 recalls were announced in September 2015.

What the numbers show

Critical
119
Severe
561
High
378
Moderate
103
Low
25

Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.

401–500 of 1186

  • SevereFDA (Drugs)·D-1693-2015·2015-09-23

    Lipotropic Methyl B-12 Injection Recalled Due to Sterility Concerns

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

    Product
    Lipotropic Methyl B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1754-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 50 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1453-2015·2015-09-23

    Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Cholecalciferol 600,000 IU/ml Injectable due to GMP violations that may impact sterility.

    Product
    Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac 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-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-1565-2015·2015-09-23

    Magnesium Sulfate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Magnesium Sulfate 500 mg/ml Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1494-2015·2015-09-23

    Fentanyl Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 2,000 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1612-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 60 mg/ml Solution due to FDA inspection findings regarding sterility and GMP violations.

    Product
    Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1633-2015·2015-09-23

    Sermorelin and GHRP-2 Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Sermorelin and GHRP-2 injections due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sermorelin 300 mcg/ml + GHRP-2 300 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-1560-2015·2015-09-23

    FDA Recalls Hydroxyprogesterone Caproate Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydroxyprogesterone Caproate injectable vials because FDA inspections found GMP violations that may compromise sterility.

    Product
    Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1646-2015·2015-09-23

    FDA Recalls Compounded Injectable Testosterone and Anastrazole Vials for Sterility Concerns

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

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1729-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Pain Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1483-2015·2015-09-23

    FDA Recalls Fentanyl Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl intrathecal solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1470-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 22 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.

    Product
    Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1506-2015·2015-09-23

    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 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1611-2015·2015-09-23

    Morphine and Fentanyl Solution Recalled for Sterility Assurance Concerns

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

    Product
    Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1570-2015·2015-09-23

    Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Methylcobalamin 10,000 mcg/ml Injectable due to GMP violations that may impact sterility.

    Product
    Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1748-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 37.5 mg sterile pellets due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1501-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

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

    Product
    Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1684-2015·2015-09-23

    Lipo-DEN III Injection Recalled for Sterility Assurance Concerns

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

    Product
    Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1695-2015·2015-09-23

    Compounded Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lipovicine-Choline and Ascorbic Acid injectable vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1784-2015·2015-09-23

    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 (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1596-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 33 mg/ml Solution due to FDA inspection findings regarding sterility assurance.

    Product
    Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1725-2015·2015-09-23

    Baclofen Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Baclofen 2,500 mcg/ml Intrathecal Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.

    Product
    Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1543-2015·2015-09-23

    FDA Recalls Hydromorphone and Baclofen Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone and Baclofen Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, 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-1772-2015·2015-09-23

    Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, 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-1776-2015·2015-09-23

    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 may impact sterility.

    Product
    Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1435-2015·2015-09-23

    Acetylcysteine Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    Acetylcysteine 100 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-1588-2015·2015-09-23

    Morphine Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Morphine 20 mg/ml Solution because FDA inspections found GMP violations that may impact sterility.

    Product
    Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V594000·2015-09-23

    Mitsubishi Mirage and i-MiEV Recalled for Air Bag Deployment Issues

    Mitsubishi is recalling 2014 Mirages and 2012 i-MiEVs because increased resistance in the impact sensor may delay or prevent air bag deployment in a crash.

    Product
    MITSUBISHI — MITSUBISHI MIRAGE, I-MIEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1657-2015·2015-09-23

    FDA Recalls Testosterone and Anastrazole Pellets Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone 60 mg Anastrazole 4 mg Pellets because an FDA inspection found GMP violations that may impact sterility.

    Product
    Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, 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-1760-2015·2015-09-23

    Testosterone Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Tri-Blend injections due to FDA inspection findings regarding sterility assurance and GMP violations.

    Product
    Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1672-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded intrathecal solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1706-2015·2015-09-23

    FDA Recalls Compounded Morphine and Fentanyl Solution Due to Sterility Concerns

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

    Product
    Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1634-2015·2015-09-23

    Sodium Ascorbate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sodium Ascorbate 500 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1664-2015·2015-09-23

    Bi-Mix #1 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Bi-Mix #1 Injectable due to FDA inspection findings of GMP violations that impact sterility assurance.

    Product
    Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1700-2015·2015-09-23

    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
  • SevereFDA (Drugs)·D-1666-2015·2015-09-23

    Bi-Mix Medium Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Bi-Mix Medium (30/1) Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1437-2015·2015-09-23

    Alprostadil Injection Recalled for Potential Sterility Issues

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

    Product
    Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1758-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

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

    Product
    Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1812-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

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

    Product
    Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1645-2015·2015-09-23

    Testosterone Cypionate and Anastrazole Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection due to GMP violations that may affect sterility.

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1675-2015·2015-09-23

    FDA Recalls Hydromorphone and Fentanyl Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone, Fentanyl, and Bupivacaine Intrathecal Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1548-2015·2015-09-23

    Hydromorphone and Bupivacaine Solution Recalled for Sterility Concerns

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

    Product
    Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1482-2015·2015-09-23

    FDA Recalls Fentanyl and Bupivacaine Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine intrathecal solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1783-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

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

    Product
    Tri-Mix (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1809-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, 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-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-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-1502-2015·2015-09-23

    Folic Acid Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Folic Acid 5 mg/ml Injection due to FDA inspection findings of GMP violations impacting sterility.

    Product
    Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1752-2015·2015-09-23

    Compounded Testosterone and Estradiol Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injections due to FDA inspection findings regarding sterility assurance.

    Product
    Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial,Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1677-2015·2015-09-23

    FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns

    The FDA is recalling a compounded intrathecal solution from The Compounding Pharmacy of America due to GMP violations that may impact sterility.

    Product
    Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1808-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix T-106/PGE 2 0.1/0.14 Injectable because an FDA inspection found GMP violations that may impact sterility.

    Product
    Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1665-2015·2015-09-23

    Bi-Mix Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Bi-Mix (20/1) Injectable due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1536-2015·2015-09-23

    FDA Recalls Hyaluronic Acid Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hyaluronic Acid Sodium and Lidocaine HCl Injection due to GMP violations that may impact sterility.

    Product
    Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1436-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Alprostadil 10 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, 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-1571-2015·2015-09-23

    Methylcobalamin Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Methylcobalamin 4,000 mcg/ml Injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, 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-1780-2015·2015-09-23

    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 (30/1/22) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1782-2015·2015-09-23

    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 (30/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1778-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1559-2015·2015-09-23

    Compounded Injectable Recall Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydroxocobalamin and Folic Acid injectable vials due to FDA-identified GMP violations affecting sterility.

    Product
    Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1624-2015·2015-09-23

    Polidocanol Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Polidocanol 1% Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2015·2015-09-23

    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 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1553-2015·2015-09-23

    FDA Recalls Hydromorphone and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution because an FDA inspection found violations that may affect sterility.

    Product
    Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1753-2015·2015-09-23

    FDA Recalls Testosterone and Estradiol Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injectable due to FDA inspection findings of GMP violations impacting sterility.

    Product
    Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1539-2015·2015-09-23

    Hyaluronidase Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hyaluronidase 175 units/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, 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-1556-2015·2015-09-23

    Hydroxocobalamin Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1740-2015·2015-09-23

    Alprostadil Injection Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling Alprostadil 100 mcg/ml injections due to FDA inspection findings that may impact sterility.

    Product
    PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1595-2015·2015-09-23

    Morphine and Clonidine Solution Recalled for Sterility Assurance Concerns

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

    Product
    Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, 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
  • HighFDA (Drugs)·D-1481-2015·2015-09-23

    Fentanyl and Clonidine Intrathecal Solution Recalled for Sterility Concerns

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

    Product
    Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2015·2015-09-23

    St Jude Merlin@home Transmitter Recalled for Backup VVI Operation

    St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.

    Product
    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
    Category
    Medical Device
    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 (Drugs)·D-1577-2015·2015-09-23

    Compounded Methylcobalamin Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling MIC+Methylcobalamin 4000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, 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 (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 (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 (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 (Devices)·Z-2766-2015·2015-09-23

    Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk

    Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.

    Product
    Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
    Category
    Medical Device
    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 vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2015·2015-09-23

    Salter Labs NebuTech Nebulizers Recalled for Loose Inspiratory Valve Cap

    Salter Labs is recalling specific NebuTech nebulizer models because the inspiratory valve cap may detach during treatment.

    Product
    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2015·2015-09-23

    Intuitive Surgical Recalls Fluorescence Imaging Kits Due to Packaging Damage

    Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.

    Product
    Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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-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 e
    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 (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-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

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