The Recall Desk

Archive

January 2017 recalls

913 recalls were announced in January 2017.

What the numbers show

Critical
104
Severe
443
High
205
Moderate
130
Low
31

Of the 913 recalls this month scored against our rubric, 11% are Critical, 49% are Severe.

401–500 of 913

  • CriticalFDA (Food)·F-1144-2017·2017-01-11

    FDA Recalls Bulk Herring in Brine for Listeria Risk

    Royal Seafood Baza, Inc. is recalling 405 bulk buckets of ready-to-eat herring in brine due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring in Brine with no brand name, packaged in bulk 25 lb. white plastic bucket and labeled in part, ** 204250 ** HERRING ISLANDSKAYA JUMBO BY PC ** (label on the metal handle of bucket)
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1142-2017·2017-01-11

    Chapel Hill Creamery Recalls Fresh Mozzarella Due to Salmonella Risk

    Chapel Hill Creamery is recalling Fresh Mozzarella products due to potential Salmonella contamination. The products were distributed in Georgia, North Carolina, South Carolina, Tennessee, and Virginia.

    Product
    Fresh Mozerella, Chapel Hill Creamery, Chapel Hill, NC 27516.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1157-2017·2017-01-11

    FDA Recalls Fresh Seafood Herring in Brine for Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated herring in brine due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring in Brine sold under the FRESH SEAFOOD label, packaged in a plastic retail container (tub), Net Wt. 46 oz. (1275g) - UPC 825512 008173 --- Produced By: R.S.B New York, NY 11691
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1140-2017·2017-01-11

    Chapel Hill Creamery Recalls Semi-Ripened New Moon Cheese for Salmonella Risk

    Chapel Hill Creamery is recalling Semi-Ripened New Moon cheese wheels due to potential Salmonella contamination. The product was distributed in five southeastern states.

    Product
    Semi-Ripened, New Moon, Chapel Hill Creamery, Chapel Hill, NC 27516, is sold retail by the each, .25 lb wheels, and by the 5 pack of .25 lb wheels at wholesale.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0908-2017·2017-01-11

    House of Flavors Recalls Peanut Butter Ice Cream for Listeria Risk

    House of Flavors, Inc. is voluntarily recalling Ashby's Sterling Peanut Butter Landslide Ice Cream because a supplier recalled peanut butter cookie dough potentially contaminated with Listeria monocytogenes.

    Product
    Ashby's Sterling Peanut Butter Landslide Ice Cream, 3 gallon container, frozen
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1166-2017·2017-01-11

    Big Red Fresh Tomatoes Recalled for Salmonella Contamination

    Big Red Tomatoes Packers is recalling 2,521 boxes of fresh tomatoes due to Salmonella contamination. The product was distributed in Kentucky, Massachusetts, Michigan, Pennsylvania, and West Virginia.

    Product
    Big Red Fresh Tomatoes, 5x6/6x6/6x7, 25 lb cardboard boxes. Distributed by Big Red Tomatoes. Kept refrigerated.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1148-2017·2017-01-11

    FDA Recalls Bulk Herring in Brine for Listeria Risk

    Royal Seafood Baza, Inc. is recalling 405 bulk buckets of refrigerated, ready-to-eat herring in brine due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring in Brine with no brand name, packaged in bulk 25 lb. white plastic bucket and labeled in part, ** 204883 ** HERRING DUNAYSKAYA BY PC ** (label on the metal handle of bucket)
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1147-2017·2017-01-11

    FDA Recalls Bulk Herring in Brine Due to Listeria Risk

    Royal Seafood Baza, Inc. is recalling 405 bulk buckets of refrigerated, ready-to-eat herring in brine due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring in Brine with no brand name, packaged in bulk 25 lb. white plastic bucket and labeled in part, ** 204744 ** HERRING MALOSOLNAYA (20 in barrel) ** (label on the metal handle of bucket)
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0836-2017·2017-01-11

    Country Fresh Fajita Mixes Recalled for Listeria Contamination

    Country Fresh Products is recalling specific Fajita Mixes due to potential Listeria monocytogenes contamination. Consumers in 12 states should check their pantries.

    Product
    Fajita Mixes, Net Wt.6oz, 9.5oz, 9.5oz, 10oz and 12oz, in clear plastic containers (sold under the Bi-Lo, Harris Teeter, Wal-Mart and Winn Dixie brand).
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0845-2017·2017-01-11

    Harris Teeter Kabob Kit Recalled for Listeria Contamination Risk

    Country Fresh Products is recalling Harris Teeter Kabob Kits due to potential Listeria monocytogenes contamination. Consumers should check their freezers for affected products.

    Product
    Harris Teeter, Kabob Kit 23oz
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1138-2017·2017-01-11

    Chapel Hill Creamery Recalls Paneer for Potential Salmonella Contamination

    Chapel Hill Creamery LLC is recalling 71.0 lbs of Paneer due to potential Salmonella contamination. The product was distributed in GA, NC, SC, TN, and VA.

    Product
    Paneer, Chapel Hill, NC 27516, is sold in cut pieces at retail and in whole wheels (about 4 lbs) wholesale.
    Category
    Food
    Distribution
    5 states
  • CriticalCPSC·17067·2017-01-11

    Bad Boy Off-Road Utility Vehicles Recalled Due to Missing Seat Belts

    Textron Specialized Vehicles is recalling about 1,100 Bad Boy off-road utility vehicles because they lack seat belts, posing a risk of serious injury or death.

    Product
    Bad Boy off-road utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0846-2017·2017-01-11

    Harris Teeter Stir Fry Vegetable Recalled for Listeria Risk

    Country Fresh Products is recalling Harris Teeter Stir Fry Vegetable 10oz packages due to potential Listeria monocytogenes contamination.

    Product
    Harris Teeter, Stir Fry Vegetable 10oz
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-1150-2017·2017-01-11

    FDA Recalls Royal Baza Herring for Potential Listeria Contamination

    Royal Seafood Baza, Inc. is recalling 200 vacuum-packed herring products due to potential Listeria monocytogenes contamination. The products were distributed across seven states.

    Product
    Refrigerated, Ready to Eat Herring in Brine sold under the ROYAL Baza label, vacuum packaged in a clear bag and labeled in part, ** ROYAL baza ** HERRING MALOSOLNAYA IN VACUUM BY PC ** UPC 204874 000269 ** 175 Lake Ave., Staten Island, NY 10303**
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1131-2017·2017-01-11

    Chapel Hill Creamery Recalls Raw Milk Cheese Due to Salmonella Risk

    Chapel Hill Creamery is recalling raw milk cheese due to potential Salmonella contamination. The product was distributed in five southeastern states.

    Product
    Calvander, raw milk, wheel is about 10 lbs, Chapel Hill Creamery, Chapel Hill, NC 27516, sold by weight both cut and whole.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0373-2017·2017-01-11

    Wells Pharmacy Recalls MIC/B-COMP+LIDO Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable vials due to a lack of assurance of sterility.

    Product
    MIC/B-COMP+LIDO 20 mg/40 mg/50 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0378-2017·2017-01-11

    Wells Pharmacy Recalls Mitomycin Solution Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 41 syringes of Mitomycin Solution Injectable because the agency could not ensure the product was sterile.

    Product
    Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2017·2017-01-11

    Wells Pharmacy Recalls Ceftazidime Ophthalmic Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 46 kits of compounded Ceftazidime Ophthalmic 2.25% due to a lack of assurance of sterility.

    Product
    Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0320-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 2 units of TriMix injection because the agency cannot assure the products are sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0420-2017·2017-01-11

    Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 237 vials of Vitamin D3 in Sesame Oil Injectable due to a lack of assurance of sterility.

    Product
    Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V026000·2017-01-11

    Subaru Recalls Vehicles Due to Passenger Air Bag Inflator Rupture Risk

    Subaru is recalling specific model years of Baja, Impreza, Forester, Legacy, Outback, and Tribeca vehicles to replace passenger air bag inflators that may rupture in a crash.

    Product
    SUBARU — SUBARU BAJA, IMPREZA, FORESTER, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V032000·2017-01-11

    Audi Recalls Vehicles Due to Passenger Air Bag Inflator Rupture Risk

    Volkswagen Group of America is recalling specific Audi models because passenger air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    AUDI — AUDI S6, S4, RS 4, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Slim Shot Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 127 vials of Slim Shot compounded between May and November 2016 due to a lack of assurance of sterility.

    Product
    Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin GT Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 920 vials of compounded Sermorelin GT nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0299-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 2,818 vials of compounded Testosterone Cypionate in Grapeseed nationwide due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0408-2017·2017-01-11

    FDA Recalls Tri 2 Injectable Due to Lack of Sterility Assurance

    Wells Pharmacy Network LLC is recalling Tri 2 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.

    Product
    Tri 2 (PAP/PHEN/ATROPINE) NR Injectable, 30 mg/3 mg/0.3 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0388-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate 9 mg Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1149-2017·2017-01-11

    FDA Recalls Royal Baza Herring for Potential Listeria Contamination

    Royal Seafood Baza, Inc. is recalling 200 vacuum-packed herring products due to potential Listeria monocytogenes contamination. The products were distributed across seven states.

    Product
    Refrigerated, Ready to Eat Herring in Brine sold under ROYAL Baza label, vacuum packaged in a clear bag and labeled in part, ** ROYAL baza ** HERRING SUPER DUNAYSKAYA IN VACUUM BY PC * UPC 204450 000263, 175 Lake Ave., Staten Island, NY 10303
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0276-2017·2017-01-11

    Tri-Coast Pharmacy Recalls MIC Ultra Cocktail Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 278 vials of MIC Ultra Cocktail nationwide due to a lack of assurance of sterility.

    Product
    MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 700mcg/Chromium Picolinate 20 mcg/Pyridoxine HCL 2mg/ml), (10 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 21 vials of Testosterone Cypionate in Sesame Oil Injectable due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2017·2017-01-11

    Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials because they may lack assurance of sterility. The recall covers products prepared between February 22, 2016, and September 14, 2016.

    Product
    Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0293-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 2,116 vials of Sermorelin Forte Plus 27 mg because the products lack assurance of sterility.

    Product
    Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling MIC+B12(M)+Carnitine injectable vials due to a lack of assurance of sterility. The recall covers 159 vials distributed nationwide.

    Product
    MIC+B12(M)+Carnitine 12.5 mg/50 mg/100 mg/1 mg/50 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compounded Drug Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 22 vials of a compounded injectable drug due to a lack of assurance of sterility.

    Product
    Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

    Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin+B12(C) Injectable Kits due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0285-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Sterile Compounded Drug

    Tri-Coast Pharmacy is recalling Quad Mix sterile compounded drug vials due to a lack of assurance of sterility.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0370-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 933 vials of MIC/B-COMP/(M)/CHROM/CARN Injectable due to a lack of assurance of sterility.

    Product
    MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling TriMix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0853-2017·2017-01-11

    Winn Dixie Mush & Garlic Herb Steak Recalled for Listeria Risk

    Country Fresh Products is recalling Winn Dixie Mush & Garlic Herb Steak due to potential Listeria monocytogenes contamination.

    Product
    Winn Dixie, Mush & Garlic Herb Steak 7.5oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0291-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 188 vials of Sermorelin Forte 12 mg because the agency could not ensure the sterile products were free from contamination.

    Product
    Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0392-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling TriMix compounded injections because the agency could not ensure the products were sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0369-2017·2017-01-11

    Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 106 vials of a compounded injectable product due to a lack of assurance of sterility.

    Product
    MIC/B12/CAR/CHR/LYS/DMG 25 mg/50 mg/50 mg/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL Injectable, 30 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0325-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Vitamin D3 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 662 vials of compounded Vitamin D3 100,000 Unit/mL in olive oil because the agency cannot assure the products are sterile.

    Product
    Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0381-2017·2017-01-11

    Wells Pharmacy Recalls NADH Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling NADH/Carnitine/Taurine/B12(M) Injectable kits because the agency could not ensure the product was sterile.

    Product
    NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0274-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Myers Cocktail #4 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 66 vials of Myers Cocktail #4 compounded between May and November 2016 due to a lack of assurance of sterility.

    Product
    Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pha
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Mineral Mix Schrader Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader because the agency cannot assure the products are sterile. The recall covers products compounded between May and November 2016.

    Product
    Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulf
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2017·2017-01-11

    Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 714 vials of Ultra-Test in Grapeseed Oil Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0279-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Pyridoxine HCL Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling compounded Pyridoxine HCL 100 mg/ml vials because there is a lack of assurance of sterility.

    Product
    Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0393-2017·2017-01-11

    Wells Pharmacy Recalls Sermorelin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 1,255 Sermorelin Acetate/GHRP (2)/Theanine Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate/GHRP (2)/Theanine 15 mg/5.4 mg/75 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0323-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Ultra Cocktail #2 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 123 vials of Ultra Cocktail #2 compounded between May and November 2016 because the agency cannot assure the products are sterile.

    Product
    Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Myers Cocktail #5 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Myers Cocktail #5 vials nationwide because the agency could not ensure the products were sterile.

    Product
    Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

    Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin injectable kits due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0337-2017·2017-01-11

    Wells Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Alprostadil 20 mcg/mL Injectable vials due to a lack of assurance of sterility.

    Product
    Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1134-2017·2017-01-11

    Chapel Hill Creamery Recalls Smoked Mozzarella for Salmonella Risk

    Chapel Hill Creamery is recalling smoked mozzarella products due to potential Salmonella contamination. The products were distributed in five southeastern states.

    Product
    Smoked Mozzarella, sold in 1 lb logs, half lb balls, Chapel Hill Creamery, Chapel Hill, NC 27516, and cherry-sized balls. At retail the half lb balls are sold by the each, packaged in water. All sizes are sold at wholesale, either packaged in water or dry packed. At retail the
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0286-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Compounded Sterile Drug Vials

    Tri-Coast Pharmacy is recalling 17 vials of Quad Mix compounded sterile drug due to a lack of assurance of sterility. The products were distributed nationwide.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1164-2017·2017-01-11

    Hale And Hearty Mulligatawny Soup Recalled for Listeria Risk

    Hale And Hearty Soups, LLC is recalling 124 bags of 6.9 lb Mulligatawny soup due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    MULLIGATAWNY, Net wt 6.9 lbs, UPC 1 80644 00041 0, packaged in a heat sealed flexible plastic bag.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0307-2017·2017-01-11

    FDA Recalls Tri-Coast Pharmacy Testosterone Propionate Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 347 vials of compounded Testosterone Propionate 100 mg/mL because the agency cannot ensure the products are sterile.

    Product
    Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1153-2017·2017-01-11

    Royal Seafood Baza Recalls Herring Fillets for Listeria Risk

    Royal Seafood Baza is recalling refrigerated herring fillets sold as 'Matjes' due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring in Brine, Herring Fillet "Matjes" sold under the FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Wt. 10.9 oz. (310g) - UPC 825512 004953 and Net Wt. 16.2 oz. (460g) - UPC 825512 004960 -- Manufactured by R.S.B. NY 10303
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0404-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Propionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 469 vials of compounded Testosterone Propionate Injectable because the agency could not ensure the product was sterile.

    Product
    Testosterone Propionate Injectable, 100 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0835-2017·2017-01-11

    Country Fresh Products Recalls Creole Mix Due to Listeria Risk

    Country Fresh Products is recalling 6oz containers of Creole Mix sold under Bi-Lo and Winn Dixie brands due to potential Listeria monocytogenes contamination.

    Product
    Creole Mix, Net Wt. 6oz, packed in clear plastic containers (sold under the Bi-Lo and Winn Dixie brands)
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0838-2017·2017-01-11

    Country Fresh Diced Tri-Peppers Recalled for Listeria Monocytogenes Contamination

    Country Fresh Products is recalling diced tri-peppers sold under Bi-Lo, Harris Teeter, and Winn Dixie brands due to potential Listeria monocytogenes contamination.

    Product
    Diced Tri-Peppers, Net Wt. 6oz and 12oz, in clear plastic containers (sold under the Bi-Lo, Harris Teeter, and Winn Dixie brand).
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-1165-2017·2017-01-11

    Hale And Hearty White Bean and Broccoli Soup Recalled for Listeria Risk

    Hale And Hearty Soups, LLC is recalling White Bean, Broccoli S.D.T. soup due to potential contamination with Listeria monocytogenes.

    Product
    WHITE BEAN, BROCCOLI S.D.T., Net wt 2 x 6.9 lbs, UPC 1 80644 00055 7, packaged in a heat sealed flexible plastic bag.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0316-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 13 vials of TriMix compounded injections because the agency could not ensure the products were sterile.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1158-2017·2017-01-11

    FDA Recalls Herring Fillets for Potential Listeria Contamination

    Royal Seafood Baza, Inc. is recalling refrigerated herring fillets due to potential Listeria monocytogenes contamination. Consumers should check their freezers for affected products.

    Product
    Refrigerated, Ready to Eat Herring Fillets in oil Lightly Salted sold under the FRESH SEAFOOD label, packaged in a plastic retail container (tub), Net Wt. 16 oz. (454g) - UPC 825512 014044 --- Produced by Royal Seafood Baza U.S.A.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0386-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy is recalling 568 Sermorelin Acetate 15 mg Injectable Kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1151-2017·2017-01-11

    Royal Seafood Baza Recalls Herring in Oil for Listeria Risk

    Royal Seafood Baza is recalling refrigerated herring in oil due to potential Listeria monocytogenes contamination. The product was distributed in seven states.

    Product
    Refrigerated, Ready to Eat Herring in Oil "Forelka Style" sold under the firm's FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Wt. 10.9 oz. (310g) - UPC 825512 004915, and Net Wt. 16.2 oz. (460g) - UPC 825512 004922 --- Manufactured by R. S. B. New York,
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0847-2017·2017-01-11

    Country Fresh Stir Fry Vegetable Recall for Listeria Risk

    Country Fresh Products is recalling Harris Teeter Stir Fry Vegetables due to potential Listeria monocytogenes contamination.

    Product
    Harris Teeter, SW Stir Fry Vegetable7oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0371-2017·2017-01-11

    Wells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 511 vials of a compounded injectable drug due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    MIC/BCOMP+CAR+ARG+CHR+LID 12.5 mg/25 mg/25 mg/25 mg/12.5 mg/0.2 mg/20 mg/mL Injectable, a) 10 mL and b) 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1154-2017·2017-01-11

    FDA Recalls Fresh Seafood Herring Fillets for Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated herring fillets in oil due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Herring Fillet in Oil sold under the FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Wt. 10.9 oz. (310g) - UPC 825512 004977, and Net Wt. 16.2 oz. (460g) - UPC 825512 004984 --- Manufactured by R.S.B., NY 10303
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1160-2017·2017-01-11

    Royal Seafood Baza Recalls Pacific Herring Fillets for Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated Pacific Herring Fillets in Oil due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, Ready to Eat Pacific Herring Fillet in Oil sold under the FRESH SEAFOOD label, packaged in a plastic retail containers (tubs), Net Wt. 9.3 oz. (265g) - UPC 825512 110258, and Net Wt. 16.2 oz. (460g) - UPC 825512 110265 --- Manufactured by R.S.B. Staten Island, NY 10
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0852-2017·2017-01-11

    Country Fresh Celery and Onion Dice Recalled for Listeria Risk

    Country Fresh Products is recalling 6-ounce containers of Celery/Onion Dice sold under Bi-Lo and Winn Dixie brands due to potential Listeria monocytogenes contamination.

    Product
    Celery/Onion Dice, Net Wt. 6oz, in clear plastic containers (sold under the Bi-Lo and Winn Dixie brands)
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0270-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Lipotropic Injections Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 987 vials of compounded Lipotropic injections nationwide because the agency could not ensure the products were sterile.

    Product
    Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2017·2017-01-11

    FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0402-2017·2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling compounded Testosterone Cypionate in Sesame Oil Injectable vials due to a lack of assurance of sterility.

    Product
    Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2017·2017-01-11

    Wells Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable Vials

    Wells Pharmacy Network LLC is recalling 16 vials of Dexamethasone Sodium Phosphate 24 mg/mL injectable due to a lack of assurance of sterility.

    Product
    Dexamethasone Sodium Phosphate 24 mg/mL (2.4%), Injectable, 2 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1159-2017·2017-01-11

    Royal Seafood Baza Recalls Herring Fillets Due to Listeria Risk

    Royal Seafood Baza, Inc. is recalling refrigerated herring fillets because they may be contaminated with Listeria monocytogenes.

    Product
    Refrigerated, Ready to Eat SUPER DUNAYSKAYA Herring Fillets in Oil sold under the FRESH SEAFOOD label, packaged in plastic retail containers (tubs), Net Weight 28.2 OZ./800 g.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0267-2017·2017-01-11

    Tri-Coast Pharmacy Recalls L-Carnitine Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 14 vials of L-Carnitine 250 mg/mL because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.

    Product
    L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1137-2017·2017-01-11

    Chapel Hill Creamery Recalls Burrata Due to Salmonella Contamination Risk

    Chapel Hill Creamery LLC is recalling retail burrata sold in water due to potential Salmonella contamination. The product was distributed in five southeastern states.

    Product
    Burrata, is sold by each, retail only, packaged in water.
    Category
    Food
    Distribution
    5 states
  • SevereCPSC·17724·2017-01-11

    Arctic Cat Recalls Snowmobiles Due to Fuel Tank Fire Hazard

    Arctic Cat is recalling about 20,700 snowmobiles because the fuel tank can crack and leak fuel into the engine compartment, posing a fire hazard.

    Product
    Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0394-2017·2017-01-11

    Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the products were sterile.

    Product
    Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0284-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling Quad Mix compounded injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.

    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0328-2017·2017-01-11

    Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 157 vials of Ultra-Test Injectable nationwide due to a lack of assurance of sterility.

    Product
    ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2017·2017-01-11

    Tri-Coast Pharmacy Recalls IV Cocktail #2 Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 132 vials of IV Cocktail #2 nationwide due to a lack of assurance of sterility.

    Product
    IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Co
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2017·2017-01-11

    Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 5,277 kits of compounded Chorionic Gonadotropin injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Chorionic Gonadotropin, Lyophilized, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0375-2017·2017-01-11

    Wells Pharmacy Recalls MIC/Chromium/B12 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 648 vials of MIC/Chromium/B12(M) Injectable because the agency cannot assure the product is sterile.

    Product
    MIC/Chromium/B12(M) Injectable, 25 mg/50 mg/50 mg/25 mcg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0333-2017·2017-01-11

    Wells Pharmacy Recalls NADH Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling NADH injectable compounded in Ocala, FL, due to a lack of assurance of sterility.

    Product
    Nicotinamide Adenine Dinucleotide (NADH) - Lyophilized (P.F.) 100 mg Injectable, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2017·2017-01-11

    Tri-Coast Pharmacy Recalls BiMix Phentolamine/Papaverine Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling BiMix Phentolamine/Papaverine vials because there is a lack of assurance of sterility. The recall covers products compounded between May and November 2016.

    Product
    BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2017·2017-01-11

    Tri-Coast Pharmacy Recalls Sermorelin Forte Plus Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling 441 vials of Sermorelin Forte Plus 18 mg because the products lack assurance of sterility. The recall covers sterile products compounded between May 17, 2016, and November 17, 2016.

    Product
    Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0314-2017·2017-01-11

    Tri-Coast Pharmacy Recalls TriMix Injection Due to Sterility Concerns

    Tri-Coast Pharmacy is recalling TriMix injections because the products may not be sterile. The recall covers vials compounded between May and November 2016.

    Product
    TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2017·2017-01-11

    Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 325 vials of Ultra-Test Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Drug
    Distribution
    Distributed nationwide

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