Drug recall: Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N…
Class II FDA enforcement event 81810. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of sterility assurance.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Promise Pharmacy, LLC started this drug recall on 17 Dec 2018. The firm address in the FDA record is in Palm Harbor, FL. FDA put the recall in Class II. FDA event 81810 has 51 product records. The first FDA enforcement report date is 20 Feb 2019. The record gives the status Terminated, with the termination date 30 Mar 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide in the USA.
Recalling firm
Promise Pharmacy, LLC, Palm Harbor, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
51 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0431-2019 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684. | 75 10 ml bottles | Class II | Terminated | 20 Feb 2019 |
| D-0432-2019 | 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 | 43 3 mL bottles | Class II | Terminated | 20 Feb 2019 |
| D-0433-2019 | 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 | 55 3 ml bottles | Class II | Terminated | 20 Feb 2019 |
| D-0434-2019 | Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | 250 3 ml bottles | Class II | Terminated | 20 Feb 2019 |
| D-0435-2019 | 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 | 2057 6 ml bottles | Class II | Terminated | 20 Feb 2019 |
| D-0436-2019 | 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 | 900 3 ml bottles | Class II | Terminated | 20 Feb 2019 |
| D-0437-2019 | Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor FL 34684 | 167 3 ml bottles | Class II | Terminated | 20 Feb 2019 |
| D-0438-2019 | 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 | 204 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0439-2019 | 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 | 3 30 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0440-2019 | Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 210 5 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0441-2019 | 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 Hwy 19N, Palm Harbor, FL 34684 | 158 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0442-2019 | Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 252 vials | Class II | Terminated | 20 Feb 2019 |
| D-0443-2019 | Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 704 vials | Class II | Terminated | 20 Feb 2019 |
| D-0444-2019 | 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 | 158 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0445-2019 | Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 288 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0446-2019 | Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 196 50 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0447-2019 | Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 94 vials | Class II | Terminated | 20 Feb 2019 |
| D-0448-2019 | 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 | 25 vials | Class II | Terminated | 20 Feb 2019 |
| D-0449-2019 | Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 255 vials | Class II | Terminated | 20 Feb 2019 |
| D-0450-2019 | Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 341 vials | Class II | Terminated | 20 Feb 2019 |
| D-0451-2019 | Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 296 vials | Class II | Terminated | 20 Feb 2019 |
| D-0452-2019 | Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 927 vials | Class II | Terminated | 20 Feb 2019 |
| D-0453-2019 | Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 416 vials | Class II | Terminated | 20 Feb 2019 |
| D-0454-2019 | Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 139 vials | Class II | Terminated | 20 Feb 2019 |
| D-0455-2019 | Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 93 vials | Class II | Terminated | 20 Feb 2019 |
| D-0456-2019 | IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 59 vials | Class II | Terminated | 20 Feb 2019 |
| D-0457-2019 | Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 30 vials | Class II | Terminated | 20 Feb 2019 |
| D-0458-2019 | Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 64 vials | Class II | Terminated | 20 Feb 2019 |
| D-0459-2019 | BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 37 vials | Class II | Terminated | 20 Feb 2019 |
| D-0460-2019 | HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 654 vials | Class II | Terminated | 20 Feb 2019 |
| D-0461-2019 | HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 2595 vials | Class II | Terminated | 20 Feb 2019 |
| D-0462-2019 | HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 819 vials | Class II | Terminated | 20 Feb 2019 |
| D-0463-2019 | Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 266 vials | Class II | Terminated | 20 Feb 2019 |
| D-0464-2019 | IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 59 vials | Class II | Terminated | 20 Feb 2019 |
| D-0465-2019 | Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 43 vials | Class II | Terminated | 20 Feb 2019 |
| D-0466-2019 | ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 846 vials | Class II | Terminated | 20 Feb 2019 |
| D-0467-2019 | 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 | 64 vials | Class II | Terminated | 20 Feb 2019 |
| D-0468-2019 | Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 5 10 mL vials | Class II | Terminated | 20 Feb 2019 |
| D-0469-2019 | Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 1 vial | Class II | Terminated | 20 Feb 2019 |
| D-0470-2019 | 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 | 5 vials | Class II | Terminated | 20 Feb 2019 |
| D-0471-2019 | Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 2 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0472-2019 | Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 5 10ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0473-2019 | 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 | 7 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0474-2019 | Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 11 10ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0475-2019 | Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 8 10ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0476-2019 | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 15 10ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0477-2019 | Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 11 10 ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0478-2019 | Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 7 vials | Class II | Terminated | 20 Feb 2019 |
| D-0479-2019 | Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 2 10ml vials | Class II | Terminated | 20 Feb 2019 |
| D-0480-2019 | Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 3 | Class II | Terminated | 20 Feb 2019 |
| D-0481-2019 | Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 | 1 10 ml vial | Class II | Terminated | 20 Feb 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2018
- 367
- Share of these events in Class II
- 60%
- Product records in this event
- 51Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Jun 2021 | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx o | Drug | Class II | 1 |
| 18 Oct 2018 | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, | Drug | Class III | 1 |
Official channels
- FDA enforcement report D-0431-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 81810. https://recallregister.com/fda/ii/81810/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide in the USA.
- What quantity of product is in FDA event 81810?
- The event has 51 product records. The first record gives this quantity:
75 10 ml bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2018 have the same class?
- 60% of the 367 drug events that started in 2018 are in Class II.