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.

26–50 of 51

  • 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…
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Bremelanotide Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 64 vials of Bremelanotide 20mg injections nationwide due to a lack of sterility assurance.

    Product
    Bremelanotide (PT 141), 20mg 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 Folic Acid Injection Due to Sterility Concerns

    Promise Pharmacy is recalling Folic Acid 5mg/ml injections because the product lacks sterility assurance. The recall covers nationwide distribution.

    Product
    Folic Acid, 5mg/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 Prednisolone Ophthalmic Solution for Sterility Concerns

    Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac ophthalmic solution due to lack of sterility assurance. The recall covers 900 bottles distributed nationwide.

    Product
    Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, 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 Trim Calm Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 7 vials of Trim Calm due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2019-02-20

    Promise Pharmacy Recalls Pyridoxine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Pyridoxine HCl, 100 mg/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 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 Zinc Sulfate Injection Due to Sterility Concerns

    Promise Pharmacy is recalling three vials of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Zinc Sulfate,10mg/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 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 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 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 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 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 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 HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 654 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 11,000 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 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 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 Methylcobalamin Injections Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 704 vials of Methylcobalamin 10,000 mcg Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Methylcobalamin lyophilized, 10,000 mcg 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 Ipamorelin Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 416 vials of Ipamorelin 9 mg injection because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Ipamorelin, 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 Myer's Cocktail Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 5 vials of Myer's Cocktail due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 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 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 Prednisolone and Gatifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 55 bottles of compounded Prednisolone and Gatifloxacin Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin 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