Promise Pharmacy Recalls Prednisolone and Bromfenac Ophthalmic Solution for Sterility Concerns
Promise Pharmacy is recalling 167 bottles of compounded Prednisolone and Bromfenac Ophthalmic Solution due to a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk defects.
Plain-English summary
Promise Pharmacy, LLC is recalling 167 3 mL bottles of Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops. The product is a compounded prescription eye drop sold under the brand Promise Pharmacy.
The recall was initiated due to a lack of sterility assurance. The affected lots are 09262018@6 with a best-use date of 12/25/2018, and 11052018@2 with a best-use date of 2/3/2019. The product was distributed nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- 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
- Manufacturer
- Promise Pharmacy, LLC
- Category
- Drug — Ophthalmic Solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 09262018@6 BUD: 12/25/2018
- 11052018@2 BUD: 2/3/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Promise Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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