The Recall Desk

FDA (Drugs) recall action 81810

Promise Pharmacy, LLC recalled 51 products on 2019-02-20

The FDA (Drugs) publishes a recall like this one as 51 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 51 pages.

Products
51
Announced
2019-02-20
Critical
0
Units
9,094

Why these products were recalled

Lack of sterility assurance.

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.

1–25 of 51

  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Glycyrrhizic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling specific lots of Glycyrrhizic Acid Injection because of a lack of sterility assurance. The affected product was distributed nationwide.

    Product
    Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Lysine HCl injection due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 75 bottles of Acetylcysteine Ophthalmic Solution because the product lacks sterility assurance. The recall covers nationwide distribution in the USA.

    Product
    Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 196 vials of Ascorbic Acid Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Amino Blend Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Amino Blend Injection because the product lacks sterility assurance. The recall covers lots distributed nationwide.

    Product
    Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 819 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 341 vials of Sermorelin/GHRP2/GHRP6 injection because the product lacks sterility assurance. The recall covers lots distributed nationwide in the USA.

    Product
    Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls BPC 157 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 37 vials of BPC 157 injections because they lack sterility assurance. The affected lot was distributed nationwide.

    Product
    BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Vitamin B Complex Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 204 vials of compounded Vitamin B Complex due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Sermorelin Theanine/GHRP2 Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Sermorelin Theanine/GHRP2 injections due to a lack of sterility assurance. The affected lot was distributed nationwide.

    Product
    Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Trim Complete Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 158 vials of Trim Complete injection nationwide due to a lack of sterility assurance.

    Product
    Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls IGF-1-LR3 Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling specific lots of Vitamin D3 50,000iu/mL injections nationwide due to a lack of sterility assurance.

    Product
    Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection nationwide due to a lack of sterility assurance.

    Product
    Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 43 bottles of compounded Prednisolone and Moxifloxacin ophthalmic solution due to a lack of sterility assurance.

    Product
    Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Prednisolone Ophthalmic Solution Due to Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls MIC B12 Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling MIC B12+L-Carnitine+Chromium injections due to a lack of sterility assurance. The recall covers 64 vials distributed nationwide.

    Product
    MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Procaine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 11 vials of Procaine HCl 2% injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Dexpanthenol Injection Vials Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 7 vials of Dexpanthenol Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 296 vials of Sermorelin/GHRP2/GHRP6 injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Folic Acid Injection, 10 mg/mL, 10mL vials due to a lack of sterility assurance. The affected lots were distributed nationwide.

    Product
    Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Multi Trace Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Multi Trace injection vials because they may lack sterility assurance. The recall covers 30 mL vials distributed nationwide.

    Product
    Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states