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.

101–200 of 1186

  • 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
  • SevereNHTSA·15V592000·2015-09-23

    FCA Recalls 2016 Ram Trucks Due to Engine Stalling Risk

    FCA is recalling 2016 Ram 2500, 3500, 4500, and 5500 trucks because a short circuit in the Engine Control Module may cause the engine to stall without warning, increasing crash risk.

    Product
    RAM — RAM 4500, 5500, 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1734-2015·2015-09-23

    Compounded Injectable Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling LIPOLEAN + Ascorbic Acid injectable vials due to FDA inspection findings of GMP violations that impact sterility.

    Product
    LIPOLEAN + Ascorbic Acid 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-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
  • SevereNHTSA·15V588000·2015-09-23

    Stealth Trailers Recall 2016 Models Due to Wheel Stud Defect

    Stealth Trailers is recalling 165 model year 2016 trailers because wheel studs may break, potentially causing the wheel to detach and increasing crash risk.

    Product
    STEALTH — STEALTH, QUALITEC LIBERTY LIMITED EDITION, CAR HAULER EXPRESS, COLDSHORE, LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1567-2015·2015-09-23

    FDA Recalls Compounded Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Methionine, Inositol, and Choline injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1685-2015·2015-09-23

    Compounded Lipoderm Injection Recalled for Sterility Assurance Concerns

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

    Product
    LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1721-2015·2015-09-23

    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 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1637-2015·2015-09-23

    Sufentanil Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sufentanil 50 mcg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1733-2015·2015-09-23

    LipoLean Injectable Recalled Due to Sterility Assurance Concerns

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

    Product
    LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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-1765-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Issues

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

    Product
    Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1590-2015·2015-09-23

    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 affecting sterility.

    Product
    Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, 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-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-1563-2015·2015-09-23

    Lidocaine and Epinephrine Vials Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Lidocaine 2% with Epinephrine 1:100,000 vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, 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-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-1795-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

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

    Product
    Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1639-2015·2015-09-23

    Compounded Injectable Recalled for Potential Sterility Issues

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

    Product
    SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1641-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 150 mg/ml Injection due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1552-2015·2015-09-23

    Hydromorphone Solution Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 5 mg/ml Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    Hydromorphone 5 mg/ml 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-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-1717-2015·2015-09-23

    Quad-Mix 2 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Quad-Mix 2 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Quad-Mix 2 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1566-2015·2015-09-23

    Mannitol 5% Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mannitol 5% Injectable vials because FDA inspections found GMP violations that may impact sterility.

    Product
    Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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 (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
  • 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-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
  • SevereNHTSA·15V589000·2015-09-23

    Forest River Recalls Cherokee and Vengeance Trailers for Wiring Fire Risk

    Forest River is recalling 2009-2016 Cherokee and Vengeance trailers because an insufficient ground wire in the wiring harness may overheat, increasing the risk of fire and loss of brakes.

    Product
    FOREST RIVER — FOREST RIVER VENGEANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1497-2015·2015-09-23

    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 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1523-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 1,250 IU/ml Injection vials because FDA inspections identified GMP violations that may impact sterility.

    Product
    HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1642-2015·2015-09-23

    Testosterone Cypionate Injection Recalled for Sterility Assurance Concerns

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

    Product
    Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1558-2015·2015-09-23

    Hydroxocobalamin Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, 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-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-1744-2015·2015-09-23

    Testosterone Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 20 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Testosterone 20 mg, Sterile Pellet, 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-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-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-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-1492-2015·2015-09-23

    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 2,000 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-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-1493-2015·2015-09-23

    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 2,000 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-1708-2015·2015-09-23

    FDA Recalls Compounded Sterile Pain Medication Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling a compounded sterile solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting sterility.

    Product
    Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1544-2015·2015-09-23

    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 GMP violations that may affect sterility.

    Product
    Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, 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-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-1513-2015·2015-09-23

    HCG Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits because an FDA inspection found GMP violations that may affect sterility.

    Product
    HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, 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-1466-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 12.5 mg sterile pellets because FDA inspections found GMP violations that may affect sterility.

    Product
    Estradiol 12.5 mg, Sterile Pellet, 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-1682-2015·2015-09-23

    FDA Recalls Intrathecal Solution Due to Sterility Assurance Concerns

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

    Product
    Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1732-2015·2015-09-23

    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 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1722-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Issues

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

    Product
    Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1800-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST9C Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1540-2015·2015-09-23

    FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Hydromorphone 0.25 mg/ml Intrathecal Solution because an FDA inspection found GMP violations that may affect sterility.

    Product
    Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 15 mg sterile pellets nationwide because FDA inspections identified GMP violations affecting sterility.

    Product
    Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, 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-1802-2015·2015-09-23

    Tri-Mix SUPER Injectable Recalled for Sterility Assurance Concerns

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

    Product
    Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, 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-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-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
  • 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-1768-2015·2015-09-23

    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 (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1777-2015·2015-09-23

    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 (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1621-2015·2015-09-23

    FDA Recalls Alprostadil Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling PGE 40 (Alprostadil) 40 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1773-2015·2015-09-23

    FDA Recalls Tri-Mix Injectable Due to Sterility Concerns

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

    Product
    Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1652-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 62.5 mg Pellets because an FDA inspection found GMP violations that may affect sterility.

    Product
    Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1477-2015·2015-09-23

    Estradiol Cypionate Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol Cypionate 5mg/ml injectable vials because FDA inspections identified GMP violations that may impact product sterility.

    Product
    Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, 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-1622-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling PGE 80 (Alprostadil) 80 mcg/ml Injection because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, 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-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-1524-2015·2015-09-23

    HCG Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling HCG 11,000 IU/ml Injection vials because FDA inspections found GMP violations that may impact sterility.

    Product
    HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1728-2015·2015-09-23

    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 5,000 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-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-1499-2015·2015-09-23

    Fentanyl Intrathecal Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Fentanyl 500 mcg/ml Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1593-2015·2015-09-23

    Morphine and Baclofen Solution Recalled Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Baclofen solution due to FDA inspection findings of GMP violations affecting sterility.

    Product
    Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1640-2015·2015-09-23

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Testosterone Cypionate 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-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-1709-2015·2015-09-23

    FDA Recalls Compounded Morphine, Fentanyl, and Baclofen Injection for Sterility Concerns

    The FDA is recalling compounded morphine, fentanyl, and baclofen injections due to GMP violations that may compromise sterility. The recall covers lots distributed nationwide between November 2014 and May 2015.

    Product
    Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, 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-1431-2015·2015-09-23

    5-MTHF Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling 5-MTHF injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1687-2015·2015-09-23

    Compounding Pharmacy Recalls LIPO-Tropic Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable vials because FDA inspections found violations that may affect sterility.

    Product
    LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1789-2015·2015-09-23

    Tri-Mix Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix AT-6 Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2015·2015-09-23

    Estradiol Pellets Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 18 mg sterile pellets due to GMP violations that may impact sterility.

    Product
    Estradiol 18 mg, Sterile Pellet, 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-1630-2015·2015-09-23

    Sermorelin/GHRP2 Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Sermorelin/GHRP2 Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Sermorelin/GHRP2 1000/1000 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-1676-2015·2015-09-23

    FDA Recalls Compounded Hydromorphone Fentanyl Bupivacaine Intrathecal Solution

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

    Product
    Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, 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
  • SevereFDA (Drugs)·D-1438-2015·2015-09-23

    Alprostadil Injection Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Alprostadil 20 mcg/ml Injection because an FDA inspection identified GMP violations that may impact sterility.

    Product
    Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, 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-1797-2015·2015-09-23

    Compounded Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable due to lack of assurance of sterility identified during an FDA inspection.

    Product
    Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1738-2015·2015-09-23

    FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution due to FDA inspection findings of GMP violations that may impact 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 (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-1517-2015·2015-09-23

    HCG and Methylcobalamin Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections due to FDA inspection findings regarding sterility and quality.

    Product
    HCG 5,000 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 (Drugs)·D-1756-2015·2015-09-23

    Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone Cypionate 220 mg/ml Injection due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Testosterone Cypionate 220 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

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