CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Acetylcysteine Ophthalmic Solution, 100mg/ml recalled
Promise Pharmacy is recalling Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, distributed nationwide in the US. The recall was initiated on 17 Dec 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0431-2019
- FDA event ID
- 81810
- Recalling firm
- Promise Pharmacy, Palm Harbor, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2018
- FDA classified
- 8 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 17 Dec 2018 | Recall initiated by company | |
| 8 Feb 2019 | Classified by FDA | +53 days |
| 20 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot: 11072018@10 BUD: 12/22/2018
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
50 other products · FDA event 81810More recalls from Promise Pharmacy
All 53| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MIC+Methyl B12 injection Methionine Inositol recalled | Promise Pharmacy | Other | 5 states |
| Drug | CLASS II | Vitamin D3 50,000iu/mL, injection recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Glutathione Injection, 200 mg/mL recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin 9 mg injection recalled by Promise Pharmacy | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL vial recalled | Promise Pharmacy | Sterility | Nationwide |
Other Acetylcysteine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine 10% Ophthalmic Solution recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine for Injection (200 mg/mL) recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |