CLASS III Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5% dropper recalled
Promise Pharmacy is recalling Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5% dropper, distributed nationwide in the US. The recall was initiated on 18 Oct 2018 and the FDA has classified it as Class III.
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-0239-2019
- FDA event ID
- 81351
- Recalling firm
- Promise Pharmacy, Palm Harbor, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Oct 2018
- FDA classified
- 8 Nov 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 18 Oct 2018 | Recall initiated by company | |
| 31 Oct 2018 | Published in enforcement report | +13 days |
| 8 Nov 2018 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of precipitate
Product as listed by the FDA
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Where it was distributed
U.S.A. Nationwide.
Questions about this recall
Why was it recalled?
Presence of precipitate
Which lots are affected?
Lot#: 04092018@2, Exp 12/03/2018
Where was it sold?
U.S.A. Nationwide.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More 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 Prednisolone recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild | AbbVie | Potency & Assay | Nationwide |
| Drug | CLASS II | Prednisolone Oral Solution, USP, 15 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Prednisolone Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |