Reported Feb 20, 2019 · Terminated
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded…
Promise Pharmacy, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Promise Pharmacy, LLC · 31818 Us Highway 19 N · Palm Harbor, FL · 34684-3713
Is this the product you have?
- Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
- Combo Drops
3 mL Rx OnlyCompounded PrescriptionPromise Pharmacy 31818 US Hwy 19NPalm Harbor FL 34684
- Lot codes and dates
- Lots09262018@5
- BUD
1/15/201910092018@1
- BUD
1/25/201911052018@1
- BUD2/21/2019
- Amount recalled
- 250 3 ml bottles
This recall covers 51 products
The agency filed one notice per product. You are reading one of them; the other 50 are below.
38 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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