FDAFDA · Food and drugs·Recall number 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
Published February 20, 2019 · Recall initiated: December 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Promise Pharmacy, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lots: 09262018@6 BUD: 12/25/2018; 11052018@2 BUD: 2/3/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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