Unrated Drug recall · FDA · Published December 17, 2018
Promise Pharmacy Acetylcysteine Ophthalmic Solution Recall: Lack of Sterility
Promise Pharmacy recalls Acetylcysteine Ophthalmic Solution (100mg/ml, 10%) due to lack of sterility assurance. Rx only product with specific lot and expiration date.
Recall notice
Lack of sterility assurance.
Contact the company
Recalling firmPromise Pharmacy, LLC31818 Us Highway 19 N · Palm Harbor, FL 34684-3713
What happened, in plain English
Promise Pharmacy is recalling Acetylcysteine Ophthalmic Solution (100mg/ml, 10%) because it lacks sterility assurance. This could lead to infections if used improperly. The product is prescription-only and sold through their compounding pharmacy. Read more at govinfonow.com/recall/39312-promise-pharmacy-acetylcysteine-ophthalmic-solution-recall-lack-of-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/39312-promise-pharmacy-acetylcysteine-ophthalmic-solution-recall-lack-of-sterility · Updated October 5, 2026 · FDA enforcement record: FDA #D-0431-2019
Cite this page
“Promise Pharmacy Acetylcysteine Ophthalmic Solution Recall: Lack of Sterility.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39312-promise-pharmacy-acetylcysteine-ophthalmic-solution-recall-lack-of-sterility. Based on FDA recall #D-0431-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0431-2019%22&limit=1).
Why it’s dangerous
The solution lacks sterility assurance, meaning it may contain harmful bacteria or contaminants. If used in the eye, this could cause serious infections or eye damage. The product is intended for prescription use only.
Who’s affected
Prescription patients who received this specific ophthalmic solution from Promise Pharmacy. Those with eye conditions requiring the medication are most at risk.
How to tell if you have this one
Check for the lot number 11072018 on the label. The product was sold by Promise Pharmacy Compounding Specialist in Palm Harbor, Florida, with an expiration date of December 22, 2018.
- Brand
Promise Pharmacy- Category
Drug
All 51 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0431-2019 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.; Lot: 11072018@10 BUD: 12/22/2018 | 75 10 ml bottles |
| 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; Lot: 10252018@8 BUD: 2/10/2019 | 43 3 mL bottles |
| 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; Lot: 11052018@4 BUD: 1/18/2019 | 55 3 ml bottles |
| 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; Lots: 09262018@5 BUD: 1/15/2019; 10092018@1 BUD: 1/25/2019; 11052018@1 BUD: 2/21/2019 | 250 3 ml bottles |
| 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; Lots: 09192018@4 BUD: 12/18/2018; 10112018@1 BUD: 12/24/2018; 10262018@1 BUD: 1/8/2019; 10302018@1 BUD: 1/12/2019; 11082018@6 BUD: 1/21/2019 | 2057 6 ml bottles |
| 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; Lots: 11012018@1 BUD: 1/14/2019; 11022018@1 BUD: 1/15/2019 | 900 3 ml bottles |
| 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; Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019 | 167 3 ml bottles |
| 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; Lots: 10092018@4 BUD: 1/7/2019; 11122018@7 BUD: 2/10/2019 | 204 10 ml vials |
| 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; Lot: 10312018@5 BUD: 12/15/2018 | 3 30 ml vials |
| 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; Lots: 09112018@10 BUD: 1/2/2019; 09212018@9 BUD: 1/12/2019; 11132018@10 BUD: 2/27/2019 | 210 5 ml vials |
| 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; Lot: 10022018@6 BUD: 12/31/2018 | 158 10 ml vials |
| D-0442-2019 | Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 08212018@11 BUD: 12/19/2018; 10012018@1 BUD: 1/29/2019 | 252 vials |
| D-0443-2019 | Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 08032018@3 BUD: 01/30/2019; 08272018@6 BUD: 2/23/2019; 09142018@4 BUD: 3/13/2019; 10012018@3 BUD: 3/30/2019 | 704 vials |
| 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; Lots: 08302018@12 BUD: 12/24/2018; 10242018@2 BUD: 2/17/2019 | 158 10 ml vials |
| D-0445-2019 | Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 09172018@7 BUD: 12/16/2018; 10292018@2 BUD: 1/27/2019 | 288 10 ml vials |
| 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; Lots: 10152018@1 BUD: 1/13/2019; 10312018@2 BUD: 1/29/2019 | 196 50 ml vials |
| D-0447-2019 | Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 08302018@8 BUD: 2/26/2019; 10012018@2 BUD: 3/30/2019; 07052018@2 BUD: 01/01/2019 | 94 vials |
| 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; Lot: 07202018@4 BUD: 1/16/2019 | 25 vials |
| D-0449-2019 | Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 06182018@2 BUD: 12/15/2018; 08212018@12 BUD: 2/17/2019; 09212018@15 BUD: 3/20/2019; 11132018@1 BUD: 5/12/2019 | 255 vials |
| 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; Lots: 07102018@3 BUD: 1/6/2019 08302018@9 BUD: 2/26/2019 | 341 vials |
| D-0451-2019 | Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 08302018@13 BUD: 2/26/2019; 09212018@14 BUD: 3/20/2019 | 296 vials |
| 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; Lots: 07052018@1 BUD: 1/1/2019; 09182018@6 BUD: 3/1/2019; 09212018@10 BUD: 3/4/2019; 10052018@1 BUD: 3/18/2019; 11062018@2 BUD: 4/19/2019 | 927 vials |
| D-0453-2019 | Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 07132018@5 BUD: 1/9/2019; 07302018@32 BUD: 1/26/2019; 09182018@7 BUD: 3/17/2019; 10192018@2 BUD: 4/17/2019 | 416 vials |
| D-0454-2019 | Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; 09212018@12 BUD: 12/20/2018; 11062018@3 BUD: 6/4/2019 | 139 vials |
| D-0455-2019 | Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 09182018@4 BUD: 3/17/2019; 10052018@3 BUD: 4/3/2019; 11132018@3 BUD: 5/12/2019 | 93 vials |
| D-0456-2019 | IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 06282018@3 BUD: 12/25/2018 | 59 vials |
| D-0457-2019 | Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 09212018@11 BUD: 12/20/2018; 11132018@4 BUD: 2/11/2019 | 30 vials |
| D-0458-2019 | Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 10192018@4 BUD: 12/18/2019; 11132018@5 BUD: 1/12/2019 | 64 vials |
| D-0459-2019 | BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 11062018@5 BUD: 2/4/2019 | 37 vials |
| 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; Lots: 06182018@5 BUD: 12/15/2018; 07102018@5 BUD: 1/6/2018; 08212018@8 BUD: 2/17/2019 | 654 vials |
| 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; Lots: 06252018@1 BUD: 12/22/2018; 07132018@7 BUD: 1/9/2019; 07262018@2 BUD: 1/22/2019; 08212018@7 BUD: 2/17/2019; 08272018@2 BUD: 2/23/2019; 09052018@2 BUD: 2/28/2019 | 2595 vials |
| 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; Lots: 07172018@15 BUD: 1/13/2019; 08272018@3 BUD: 2/23/2019 | 819 vials |
| D-0463-2019 | Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 07102018@4 BUD: 1/6/2019; 09142018@6 BUD: 3/13/2019; 10052018@4 BUD: 4/3/2019; 11062018@1 BUD: 5/5/2019 | 266 vials |
| D-0464-2019 | IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 06282018@2 BUD: 12/25/2018 | 59 vials |
| D-0465-2019 | Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 07202018@3 BUD: 1/13/2019; 09212018@13 BUD: 2/28/2019 | 43 vials |
| 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; Lots: 09262018@1 BUD: 12/25/2018; 10232018@5 BUD: 1/21/2019; 11012018@3 BUD: 1/30/2019 | 846 vials |
| 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; Lot: 10102018@1 BUD: 1/8/2019 | 64 vials |
| 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; Lots: 11062018@13 BUD: 12/21/2018; 11072018@24 BUD: 12/22/2018 | 5 10 mL vials |
| D-0469-2019 | Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 11022018@9 BUD: 12/17/2018 | 1 vial |
| 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; Lot: 11072018@2 BUD: 12/14/2018 | 5 vials |
| D-0471-2019 | Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 11132018@9 BUD: 12/28/2018; | 2 10 ml vials |
| 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; Lots: 11022018@4 BUD: 12/17/2018; | 5 10ml vials |
| 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; Lot: 11052018@7 BUD: 12/20/2018 | 7 10 ml vials |
| D-0474-2019 | Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lots: 11082018@4 BUD: 12/23/2018; 10302018@4 BUD: 12/14/2018 | 11 10ml vials |
| 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; Lot: 10302018@3 BUD: 12/14/2018 | 8 10ml vials |
| 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; Lot: 10312018@3 BUD: 12/15/2018 | 15 10ml vials |
| D-0477-2019 | Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 11132018@8 BUD: 12/28/2018 | 11 10 ml vials |
| D-0478-2019 | Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 11052018@5 BUD: 12/20/2018 | 7 vials |
| D-0479-2019 | Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 11052018@6 BUD: 12/20/2018 | 2 10ml vials |
| D-0480-2019 | Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 10302018@7, BUD 12/14/2018 | 3 |
| D-0481-2019 | Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684; Lot: 10302018@8, BUD 12/14/2018 | 1 10 ml vial |
What to do — step by step
Check Product Label
Look for the lot number 11072018 on the label to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0431-2019 (December 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0431-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.