The Recall Desk

FDA (Drugs) recall action 75289

Wells Pharmacy Network LLC recalled 97 products on 2017-01-11

The FDA (Drugs) publishes a recall like this one as 97 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 97 pages.

Products
97
Announced
2017-01-11
Critical
0
Units
43,614

Why these products were recalled

Lack of Assurance of Sterility

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 97

  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 146 vials of compounded Testosterone Cypionate Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, 20 mg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 42 vials of Trimix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Trimix Injectable 30 mg/2 mg/40 mcg, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls B-Complex Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling B-complex + Vit C injectable vials due to a lack of assurance of sterility.

    Product
    B-complex + Vit C 20 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Vitamin D3 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 335 vials of Vitamin D3 in Sesame Oil Injectable due to a lack of assurance of sterility.

    Product
    Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Tri-Test 200 Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 550 vials of Tri-Test 200 Injectable because there is a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Tri-Test 200 (CEP 100-75-25) Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls DMSO and Lidocaine Solution Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 438 vials of DMSO with Lidocaine solution because the product lacks assurance of sterility.

    Product
    DMSO (Dimethyl Sulfoxide) with Lidocaine 50%/0.5% mL Solution, 50 mL bottle, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Mitomycin Injectable Kits Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 2,336 Mitomycin 40 mg Injectable kits nationwide due to a lack of assurance of sterility.

    Product
    Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··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
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the agency could not ensure the product was sterile.

    Product
    Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls QUAD1 Injectable Vials Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling QUAD1 injectable vials because the FDA determined there is a lack of assurance of sterility.

    Product
    QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile.

    Product
    Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2017-01-11

    Wells Pharmacy Recalls MIC/B-Complex Injectable Due to Sterility Concerns

    Wells Pharmacy Network LLC is recalling 984 vials of MIC/B-Complex Injectable because the product lacks assurance of sterility.

    Product
    MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
    Category
    Distribution
    0 states